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- What is a Clinical Trial?
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- Phases of a Clinical Trial
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- Open Oncology Clinical Trials
- Clinical Trials at Other Facilitites
Summary of Open Oncology Protocols
Select Oncology Protocol Site:
Protocol: Brain - RTOG R0627
Title
Phase II Trial of Dasatinib in Patients with Recurrent Glioblastoma Multiforme
Phase II Trial of Dasatinib in Patients with Recurrent Glioblastoma Multiforme
Treatment
Temporarily closed to patient enrollment while data is analyzed.
Dasatinib 100 mg BID. Continues until progression.
Temporarily closed to patient enrollment while data is analyzed.
Dasatinib 100 mg BID. Continues until progression.
Eligibility
Temporarily closed to patient enrollment while data is analyzed.
Histological proof of Glioblastoma. Prior treatment with Temozolomide/RT required. No other chemo is allowed. Previous participation in RTOG 0525 is allowed. Age >/=18. Performance Status >/= 60%.
Temporarily closed to patient enrollment while data is analyzed.
Histological proof of Glioblastoma. Prior treatment with Temozolomide/RT required. No other chemo is allowed. Previous participation in RTOG 0525 is allowed. Age >/=18. Performance Status >/= 60%.
Protocol: Breast - ECOG E5103
Title
A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer
A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer
Treatment
STEP 1: Arm A: AC X 4 + Placebo every 14 or 21 days X 4 followed by Paclitaxel every week X 12 + Placebo every 21 days X 4
ARM B: AC X 4 + Bev every 14 or 21 days X 4 followed by Paclitaxel every week X 12 + Bev every 21 days X 4
ARM C: AC X 4 + Bev every 14 or 21 days X 4 followed by Paclitaxel every week X 12 + Bev every 21 days X 4
STEP 2: Arm D: Prior ARM C Patients ONLY: Bevacuzumab every 21 days X 10
STEP 1: Arm A: AC X 4 + Placebo every 14 or 21 days X 4 followed by Paclitaxel every week X 12 + Placebo every 21 days X 4
ARM B: AC X 4 + Bev every 14 or 21 days X 4 followed by Paclitaxel every week X 12 + Bev every 21 days X 4
ARM C: AC X 4 + Bev every 14 or 21 days X 4 followed by Paclitaxel every week X 12 + Bev every 21 days X 4
STEP 2: Arm D: Prior ARM C Patients ONLY: Bevacuzumab every 21 days X 10
Eligibility
Histologically confirmed adenocarcinoma of the breast at significant risk of distant recurrence based on at least one of the following: Involvement of 1 lymph node on routine histologic exam; ER negative >/= 1 cm; ER+ tumor >/+ 5 cms regardless of recurrence score; ER+ tumor >/= 1 cm < 5 cm with recurrence score of >/= 11(may also be enrolled in the TailorX Trial); Completed definitive breast surgery; Margins histologically free of IBC or DCIS(LCIS allowed); Must start tx between day 28 and 84 from surgery;Must have RT if undergone BCS or undergone mastectomy with tumor > 5 cm or 4+ LNs; No HER2+; No inflammatory or fixed LNs at diagnosis; No Prior Chemo/Hormonal therapy for this breast cancer; No prior anthracycline, anthracenedione or taxane; Prior use of tamoxifen(prevention) and raloxifine must be discontinued at study entry
Histologically confirmed adenocarcinoma of the breast at significant risk of distant recurrence based on at least one of the following: Involvement of 1 lymph node on routine histologic exam; ER negative >/= 1 cm; ER+ tumor >/+ 5 cms regardless of recurrence score; ER+ tumor >/= 1 cm < 5 cm with recurrence score of >/= 11(may also be enrolled in the TailorX Trial); Completed definitive breast surgery; Margins histologically free of IBC or DCIS(LCIS allowed); Must start tx between day 28 and 84 from surgery;Must have RT if undergone BCS or undergone mastectomy with tumor > 5 cm or 4+ LNs; No HER2+; No inflammatory or fixed LNs at diagnosis; No Prior Chemo/Hormonal therapy for this breast cancer; No prior anthracycline, anthracenedione or taxane; Prior use of tamoxifen(prevention) and raloxifine must be discontinued at study entry
Protocol: Breast - ECOG PACCT1
Title
Phase III Randomized Study of Adjuvant Combination Chemotherapy and Hormonal Therapy vs Adjuvant Hormonal Therapy Alone in Women With Previously Resected Axillary Node-Negative Breast Cancer With Various Levels of Risk for Recurrence (TAILORx Trial)
Phase III Randomized Study of Adjuvant Combination Chemotherapy and Hormonal Therapy vs Adjuvant Hormonal Therapy Alone in Women With Previously Resected Axillary Node-Negative Breast Cancer With Various Levels of Risk for Recurrence (TAILORx Trial)
Treatment
Based on Oncotype DX Assay score: Arm A: Hormonal Therapy; Arm B: Hormonal Therapy; Arm C: Chemotherapy and Hormonal Therapy; Arm D: Chemotherapy and Hormonal Therapy. Patients who have had breast conservation surgery must have Radiation Therapy.
Based on Oncotype DX Assay score: Arm A: Hormonal Therapy; Arm B: Hormonal Therapy; Arm C: Chemotherapy and Hormonal Therapy; Arm D: Chemotherapy and Hormonal Therapy. Patients who have had breast conservation surgery must have Radiation Therapy.
Eligibility
ER Positive and/or PR Positive. Axillary Node Negative. Candidate for adjuvant cytotoxic therapy in addition to hormonal therapy.
ER Positive and/or PR Positive. Axillary Node Negative. Candidate for adjuvant cytotoxic therapy in addition to hormonal therapy.
Protocol: Breast - NSABP B-39 / RTOG 0413
Title
A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) vs Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer
A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) vs Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer
Treatment
Group 1: Whole Breast Radiation Therapy 45 - 50 Gy in 25 fractions, followed by optional boost.
Group 2: Partial Breast Radiation Therapy 38.5 Gy in 3.85 Gy fractions using 3D conformal external beam radiation.
Group 1: Whole Breast Radiation Therapy 45 - 50 Gy in 25 fractions, followed by optional boost.
Group 2: Partial Breast Radiation Therapy 38.5 Gy in 3.85 Gy fractions using 3D conformal external beam radiation.
Eligibility
Stage 0, 1, or 2 breast cancer. If stage 2, tumor size must be <3cm. Clear margins. No more than 3 histological positive axillary nodes. Women who are >50 with DCIS only, or over 50 with invasive, node neg and hormone positive are not eligible.
Stage 0, 1, or 2 breast cancer. If stage 2, tumor size must be <3cm. Clear margins. No more than 3 histological positive axillary nodes. Women who are >50 with DCIS only, or over 50 with invasive, node neg and hormone positive are not eligible.
Protocol: Breast - NSABP B-42
Title
A Clinical Trial to Determine the Efficacy of 5 Years of Letrozole vs Placebo in Patients Completing 5 Years of Hormonal Therapy Consisting of an AI or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Post-menopausal Women with Hormone Receptor Positive Cancer.
A Clinical Trial to Determine the Efficacy of 5 Years of Letrozole vs Placebo in Patients Completing 5 Years of Hormonal Therapy Consisting of an AI or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Post-menopausal Women with Hormone Receptor Positive Cancer.
Treatment
Group 1: Placebo taken orally once daily for 5 years.
Group 2: Letrozole 2.5 mg taken orally once daily for 5 years.
Group 1: Placebo taken orally once daily for 5 years.
Group 2: Letrozole 2.5 mg taken orally once daily for 5 years.
Eligibility
Postmenopausal. Pathologic or clinical stage I, II, IIIA. ER and/or PgR positive. Hormonal therapy must have consisted of an AI or a combo of up to 3 years Tamoxifen followed by an AI. Tamoxifen may not have been given during years 4 & 5 of adjuvant hormonal therapy.
Postmenopausal. Pathologic or clinical stage I, II, IIIA. ER and/or PgR positive. Hormonal therapy must have consisted of an AI or a combo of up to 3 years Tamoxifen followed by an AI. Tamoxifen may not have been given during years 4 & 5 of adjuvant hormonal therapy.
Protocol: Breast - OHSU 4318
Title
A Phase II Open-Label Study of Sorafenib Plus Fulvestrant as Salvage Therapy For Hormone Receptor Positive Metastatic Breast Cancer Failing Prior Aromatase Inhibitor Treatment
A Phase II Open-Label Study of Sorafenib Plus Fulvestrant as Salvage Therapy For Hormone Receptor Positive Metastatic Breast Cancer Failing Prior Aromatase Inhibitor Treatment
Treatment
Fulvestrant loading dose of 500mg IM on day 1, then 250mg IM on day 15. Upon completion of the loading dose, a fixed dose of fulvestrant 250mg IM will be administered on day 1 of the next 28 day cycle and every consecutive cycle, every 28 days. Plus Sorafenib 400 mg orally, twice daily.
Fulvestrant loading dose of 500mg IM on day 1, then 250mg IM on day 15. Upon completion of the loading dose, a fixed dose of fulvestrant 250mg IM will be administered on day 1 of the next 28 day cycle and every consecutive cycle, every 28 days. Plus Sorafenib 400 mg orally, twice daily.
Eligibility
Incurable locally advanced or metastatic breast cancer with measurable or evaluable disease. Subjects with bone only mets that can be imaged with bone scan and MRI or bone scan and plain x-ray are eligible. Must be hormone receptor positive defined as >=10%. Must be Her2neg. Patients must have received a third generation aromatase inhibitor and progressed through prior palliative therapy, recurred while on an adjuvant aromatase inhibitor, or recurred within 12 months of completing an adjuvant aromatase inhibitor. Concurrent use of bisphophonates will be permitted on this study. Male or female subjects are ok. Female subjects must be post-menopausal. Lab values must be WNL.
Incurable locally advanced or metastatic breast cancer with measurable or evaluable disease. Subjects with bone only mets that can be imaged with bone scan and MRI or bone scan and plain x-ray are eligible. Must be hormone receptor positive defined as >=10%. Must be Her2neg. Patients must have received a third generation aromatase inhibitor and progressed through prior palliative therapy, recurred while on an adjuvant aromatase inhibitor, or recurred within 12 months of completing an adjuvant aromatase inhibitor. Concurrent use of bisphophonates will be permitted on this study. Male or female subjects are ok. Female subjects must be post-menopausal. Lab values must be WNL.
Protocol: Breast - S0622
Title
Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer
Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer
Treatment
Treatment Arm 1: Dasatinib 100 mg daily, by mouth.
Treatment Arm 2: Dasatinib 70 mg twice daily, by mouth.
Treatment Arm 1: Dasatinib 100 mg daily, by mouth.
Treatment Arm 2: Dasatinib 70 mg twice daily, by mouth.
Eligibility
Women or men with Stage IV breast cancer which is bone-predominant.
Women or men with Stage IV breast cancer which is bone-predominant.
Protocol: Breast - SWOG S0230
Title
Phase III Trial of LHRH Analog Administration during Chemotherapy to Reduce Ovarian Failure following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
Phase III Trial of LHRH Analog Administration during Chemotherapy to Reduce Ovarian Failure following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
Treatment
Treatment Arm 1: Standard Adjuvant Chemotherapy
Treatment Arm 2: Standard Adjuvant Chemotherapy with Goserelin. Goserlin is given once every 4 weeks during chemotherapy.
Treatment Arm 1: Standard Adjuvant Chemotherapy
Treatment Arm 2: Standard Adjuvant Chemotherapy with Goserelin. Goserlin is given once every 4 weeks during chemotherapy.
Eligibility
Operable stage I, II, or IIIA invasive breast cancer. Tumors must be ER & PR negative. Must be premenopausal. Must have modified radical mastectomy or local excision plus axillary lymph node dissection and/or sentinel node. Planned treatment must include 3-8 cycles of chemotherapy.
Operable stage I, II, or IIIA invasive breast cancer. Tumors must be ER & PR negative. Must be premenopausal. Must have modified radical mastectomy or local excision plus axillary lymph node dissection and/or sentinel node. Planned treatment must include 3-8 cycles of chemotherapy.
Protocol: Cervical - GOG 0219
Title
A Phase III Randomized Trial of Weekly Cisplatin and Radiation vs Cisplatin and Tirapazamine and Radiation in Stage IB2, IIA, IIB, IIIB, and IVA Cervical Carcinoma Limited to the Pelvis
A Phase III Randomized Trial of Weekly Cisplatin and Radiation vs Cisplatin and Tirapazamine and Radiation in Stage IB2, IIA, IIB, IIIB, and IVA Cervical Carcinoma Limited to the Pelvis
Treatment
Arm 1: Cisplatin 40mg/m2(max=70 mg) IV over 1 hour weekly X 6 cycles with concurrent Radiation Therapy.
Arm 2: Cisplatin 75 mg/m2 (max=140 mg)IV over 1 hour, days 1,15,29. Tirapazamine 290 mg/m2 (max=385mg) IV over 2 hours days 8,10,12,22,24,26 concurrent with Radiation Therapy X 6 cycles.
Arm 1: Cisplatin 40mg/m2(max=70 mg) IV over 1 hour weekly X 6 cycles with concurrent Radiation Therapy.
Arm 2: Cisplatin 75 mg/m2 (max=140 mg)IV over 1 hour, days 1,15,29. Tirapazamine 290 mg/m2 (max=385mg) IV over 2 hours days 8,10,12,22,24,26 concurrent with Radiation Therapy X 6 cycles.
Eligibility
Patients with primary, untreated histologically confirmed invasive squamous, adeno, or adenosquamous of the cervix. Stages IB2, IIA, IIB, and IVA. Must have negative, non-suspicious para-aortic nodes. Stage IIIA (lower one-third vaginal involvement) are not eligible.
Patients with primary, untreated histologically confirmed invasive squamous, adeno, or adenosquamous of the cervix. Stages IB2, IIA, IIB, and IVA. Must have negative, non-suspicious para-aortic nodes. Stage IIIA (lower one-third vaginal involvement) are not eligible.
Protocol: CML - CSTI571A2402
Title
A Worldwide, Observational Registry collecting Longitudinal Data on the Management of Chronic Myelogenous Leukemia (CML) Patients (The WORLD CML Registry) in Routine Practice
A Worldwide, Observational Registry collecting Longitudinal Data on the Management of Chronic Myelogenous Leukemia (CML) Patients (The WORLD CML Registry) in Routine Practice
Treatment
Not a treatment protocol
Not a treatment protocol
Eligibility
Diagnosed with any phase ph+ or bcr-abl confirmed CML within 6 months of entry into the Registry. Provided informed consent.
Diagnosed with any phase ph+ or bcr-abl confirmed CML within 6 months of entry into the Registry. Provided informed consent.
Protocol: Colon - ECOG E5202
Title
Randomized Phase III Study Comparing FOLFOX Chemotherapy vs. FOLFOX Chemotherapy with Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers
Randomized Phase III Study Comparing FOLFOX Chemotherapy vs. FOLFOX Chemotherapy with Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers
Treatment
Based on tumor block risk assessment: High risk patients are randomized to Arm A or Arm B. Low risk patients are on Arm C.
Arm A: FOLFOX every 2 weeks for a total of 12 cycles.
Arm B: FOLFOX plus Bevacizumab every 2 weeks for 12 cycles. Then Bevacizumab alone every 2 weeks for 12 cycles.
Arm C: Observation.
Based on tumor block risk assessment: High risk patients are randomized to Arm A or Arm B. Low risk patients are on Arm C.
Arm A: FOLFOX every 2 weeks for a total of 12 cycles.
Arm B: FOLFOX plus Bevacizumab every 2 weeks for 12 cycles. Then Bevacizumab alone every 2 weeks for 12 cycles.
Arm C: Observation.
Eligibility
Histologically confirmed adenocarcinoma of the colon that is Stage II (T3,4 NO,MO). Distal extent of tumor must be >/= 12 cm from the anal verge as determined via endoscopy or surgery. Patients must have >/= 8 lymph nodes evaluable and reported. Patients must have paraffin-embedded tumor specimen available for central evaluation and risk assessment. No isolated, distant, or intra-abdominal mets. Patients must not have presented with complete obstruction or perforation of the bowel. No prior radiation therapy for this malignancy. Must have post-operative evidence of adequate hepatic and renal function.
Histologically confirmed adenocarcinoma of the colon that is Stage II (T3,4 NO,MO). Distal extent of tumor must be >/= 12 cm from the anal verge as determined via endoscopy or surgery. Patients must have >/= 8 lymph nodes evaluable and reported. Patients must have paraffin-embedded tumor specimen available for central evaluation and risk assessment. No isolated, distant, or intra-abdominal mets. Patients must not have presented with complete obstruction or perforation of the bowel. No prior radiation therapy for this malignancy. Must have post-operative evidence of adequate hepatic and renal function.
Protocol: Colon - NCCTG N0147
Title
Randomized Phase III Trial of Oxaliplatin Plus 5-FU/Leucovorin (FOLFOX) with or without Cetuximab after Curative Resection of Patients with Stage III Colon Cancer
Randomized Phase III Trial of Oxaliplatin Plus 5-FU/Leucovorin (FOLFOX) with or without Cetuximab after Curative Resection of Patients with Stage III Colon Cancer
Treatment
Arm A: FOLFOX - Give twelve 14 day cycles.
Arm B: FOLFOX plus Cetuximab - give twelve, 14 day cycles.
Arm A: FOLFOX - Give twelve 14 day cycles.
Arm B: FOLFOX plus Cetuximab - give twelve, 14 day cycles.
Eligibility
Histologically documented adenocarcinoma of the colon that has been completely resected. At least 1 pathologically confirmed positive lymph node identified. No evidence of residual lymph node disease. Randomization must occur <56 days post surgery. Patients with > one synchronous primary colon cancer are eligible. Performance Status 0-2. No distant metastatic disease and no prior chemo or radiation therapy. Patients with certain cardiac conditions are ineligible.
Histologically documented adenocarcinoma of the colon that has been completely resected. At least 1 pathologically confirmed positive lymph node identified. No evidence of residual lymph node disease. Randomization must occur <56 days post surgery. Patients with > one synchronous primary colon cancer are eligible. Performance Status 0-2. No distant metastatic disease and no prior chemo or radiation therapy. Patients with certain cardiac conditions are ineligible.
Protocol: Colon - OHSU 3753
Title
Phase II Study of Erlotinib (Tarceva) Alternating with Chemotherapy for Second-line Treatment of Metastatic Colorectal Cancer with Molecular Correlates for p53 Pathway
Phase II Study of Erlotinib (Tarceva) Alternating with Chemotherapy for Second-line Treatment of Metastatic Colorectal Cancer with Molecular Correlates for p53 Pathway
Treatment
Pending IRB Review Dec 2008
FOLFOX6 or FOLFIRI (delivered days 1, 2 and days 14, 15) alternating with erlotinib (days 3 thru 8 and days 16 thru 21). Erlotinib 100 mgs orally every day. FOLFOX6 (oxaliplatin 85mgs/m2 d1; 5FU 400mgs/m2 d1; LV 400mgs/m2 d1; CIV 5FU 2400mgs/m2 over 46 hours). FOLFIRI (irinotecan 180mgs/m2 d1; 5FU 400mgs/m2 d1; LV 400mgs/m2 d1; CIV 5FU 2400mgs/m2 over 46 hours). Erlotinib 100 mgs orally every day will start on days 3 and 16 immediately after the 5FU pump is unhooked. Erlotinib is discontinued on days 8 and 21 in order to permit sufficient washout (based on t1/2 of 36 hours) prior to next cycle of chemotherapy.
Pending IRB Review Dec 2008
FOLFOX6 or FOLFIRI (delivered days 1, 2 and days 14, 15) alternating with erlotinib (days 3 thru 8 and days 16 thru 21). Erlotinib 100 mgs orally every day. FOLFOX6 (oxaliplatin 85mgs/m2 d1; 5FU 400mgs/m2 d1; LV 400mgs/m2 d1; CIV 5FU 2400mgs/m2 over 46 hours). FOLFIRI (irinotecan 180mgs/m2 d1; 5FU 400mgs/m2 d1; LV 400mgs/m2 d1; CIV 5FU 2400mgs/m2 over 46 hours). Erlotinib 100 mgs orally every day will start on days 3 and 16 immediately after the 5FU pump is unhooked. Erlotinib is discontinued on days 8 and 21 in order to permit sufficient washout (based on t1/2 of 36 hours) prior to next cycle of chemotherapy.
Eligibility
Pending IRB Review Dec 2008
Age 18-80. Biopsy proven unresectable metastatic adeno of the color or rectum. Documented progression on prior first-line oxaliplatin-based or irinotecan-based regimen for metastatic colorectal cancer. Measurable disease of at least >1cm. First-line treatmetn must have been completed at least 4 weeks prior to study trx. Use of biologic agents with first-line chemotherapy permitted. Previous adjuvant regimens must have been greater than 6 months before inclusion. Adequate oregon function. No prior trx with erlotinib or gefitinib. No CNS mets. No untreated or unresolved bowel obstruction. No angina or uncontrolled CHF.
Pending IRB Review Dec 2008
Age 18-80. Biopsy proven unresectable metastatic adeno of the color or rectum. Documented progression on prior first-line oxaliplatin-based or irinotecan-based regimen for metastatic colorectal cancer. Measurable disease of at least >1cm. First-line treatmetn must have been completed at least 4 weeks prior to study trx. Use of biologic agents with first-line chemotherapy permitted. Previous adjuvant regimens must have been greater than 6 months before inclusion. Adequate oregon function. No prior trx with erlotinib or gefitinib. No CNS mets. No untreated or unresolved bowel obstruction. No angina or uncontrolled CHF.
Protocol: Esophageal - R0436
Title
A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer Who are Treated Without Surgery
A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer Who are Treated Without Surgery
Treatment
Treatment Arm 1: Radiation Therapy + Paclitaxel + Cisplatin + Cetuximab
Treatment Arm 2: Radiation Therapy + Paclitaxel + Cisplatin
Treatment Arm 1: Radiation Therapy + Paclitaxel + Cisplatin + Cetuximab
Treatment Arm 2: Radiation Therapy + Paclitaxel + Cisplatin
Eligibility
Histologically proven diagnosis, via endoscopy, of primary squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction within 6 weeks of registration. All disease must be encompassed in the radiotherapy field. Stage T1N1MO; T2-4,Any N, MO; Any T, Any N, M1a. Patient's total caloric intake must be at least 1500 calories a day. No evidence of tracheoesophageal fistula or invasion into the major bronchi. No prior chemotherapy for esophageal cancer.
Histologically proven diagnosis, via endoscopy, of primary squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction within 6 weeks of registration. All disease must be encompassed in the radiotherapy field. Stage T1N1MO; T2-4,Any N, MO; Any T, Any N, M1a. Patient's total caloric intake must be at least 1500 calories a day. No evidence of tracheoesophageal fistula or invasion into the major bronchi. No prior chemotherapy for esophageal cancer.
Protocol: Gastric / GE Junction - C80101
Title
Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma
Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma
Treatment
ARM A: Cycles 1,3,4: Leucovorin + 5-FU given on days 1 through 5, every 28 days.
Cycle 2: Continuous infusion of 5-FU + Radiation Therapy lasting approximately 5-6 weeks.
ARM B: Cycle 1: ECF - Epirubicin + Cisplatin given on day 1; 5-FU continuous infusion given on day 1 through day 21.
Cycle 2: Continuous infusion of 5-FU + Radiation Therapy lasting approximately 5-6 weeks.
Cycle 3,4: ECF - reduced rate of Epirubicin + Cisplatin given on day 1; 5-FU continuous infusion given on day 1 through day 21.
There will be no interruption of infusional 5-FU between cycles 3 and 4. Cycle 3 will end on day 21, Cycle 4 will begin on day 22.
ARM A: Cycles 1,3,4: Leucovorin + 5-FU given on days 1 through 5, every 28 days.
Cycle 2: Continuous infusion of 5-FU + Radiation Therapy lasting approximately 5-6 weeks.
ARM B: Cycle 1: ECF - Epirubicin + Cisplatin given on day 1; 5-FU continuous infusion given on day 1 through day 21.
Cycle 2: Continuous infusion of 5-FU + Radiation Therapy lasting approximately 5-6 weeks.
Cycle 3,4: ECF - reduced rate of Epirubicin + Cisplatin given on day 1; 5-FU continuous infusion given on day 1 through day 21.
There will be no interruption of infusional 5-FU between cycles 3 and 4. Cycle 3 will end on day 21, Cycle 4 will begin on day 22.
Eligibility
Histologically diagnosed adenocarcinoma of stomach or gastroesophageal junction.Patients must have had en bloc resection of all known tumor with curative intent.Patients must have tumor extension beyond muscularis propria and/or nodal involvement. No known unresected tumor, recurent cancer, microscopic evidence of tumor at the distal or proximal line of stomach rescetion, or noncontiguous resection allowed. No M1 disease. No previous chemo, or RT. Patient must have stable weight for at least one week prior to registration. Must be evaluated by a radiation oncologist.
Histologically diagnosed adenocarcinoma of stomach or gastroesophageal junction.Patients must have had en bloc resection of all known tumor with curative intent.Patients must have tumor extension beyond muscularis propria and/or nodal involvement. No known unresected tumor, recurent cancer, microscopic evidence of tumor at the distal or proximal line of stomach rescetion, or noncontiguous resection allowed. No M1 disease. No previous chemo, or RT. Patient must have stable weight for at least one week prior to registration. Must be evaluated by a radiation oncologist.
Protocol: GIST - S0502
Title
A Phase III Randomized Study of Imatinib, with or without Bevacizumab (NSC-704865), in Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors
A Phase III Randomized Study of Imatinib, with or without Bevacizumab (NSC-704865), in Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors
Treatment
Treatment Arm 1: Imatinib orally every day plus bevacizumab IV every three weeks.
Treatment Arm 2: Imatinib orally every day.
Treatment Arm 1: Imatinib orally every day plus bevacizumab IV every three weeks.
Treatment Arm 2: Imatinib orally every day.
Eligibility
Biopsy proven GIST that is distantly metastatic or unresectable. Measurable and/or non-measurable disease. May have received traditional chemo agents. At least 28 days since completion. No prior imatinib, bevacizumab, or other agents targeting KIT, VEGF, VEGFR, or PDGFR for advanced disease. Those agents may have been used in the adjuvant setting if patient did not recur for at least 12 months following therapy. Prior RT allowed if 28 days post.
Biopsy proven GIST that is distantly metastatic or unresectable. Measurable and/or non-measurable disease. May have received traditional chemo agents. At least 28 days since completion. No prior imatinib, bevacizumab, or other agents targeting KIT, VEGF, VEGFR, or PDGFR for advanced disease. Those agents may have been used in the adjuvant setting if patient did not recur for at least 12 months following therapy. Prior RT allowed if 28 days post.
Protocol: Head and Neck - LORHAN Registry
Title
Prospective, Longitudinal, Multi-Center, Descriptive Registry of Patients Receiving Therapy other than Surgical Resection Alone for Newly Diagnosed Head and Neck Carcinoma.
Prospective, Longitudinal, Multi-Center, Descriptive Registry of Patients Receiving Therapy other than Surgical Resection Alone for Newly Diagnosed Head and Neck Carcinoma.
Treatment
Not a treatment protocol.
Not a treatment protocol.
Eligibility
Histologically or cytologically confirmed new diagnosis of carcinoma involving the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or neck node metastasis from unknown origin. Scheduled to receive radiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy. Written informed consent. Registry participation does not exclude participation in clinical trials. Patients scheduled to receive, or who have received surgery, are eligible for registry participation as long as they are also scheduled to receive medical therapy.
Histologically or cytologically confirmed new diagnosis of carcinoma involving the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or neck node metastasis from unknown origin. Scheduled to receive radiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy. Written informed consent. Registry participation does not exclude participation in clinical trials. Patients scheduled to receive, or who have received surgery, are eligible for registry participation as long as they are also scheduled to receive medical therapy.
Protocol: Lung - CALGB 30607
Title
Randomized, Phase III, Placebo-Controlled Trial of Sunitinib as Maintenance Therapy in Non-Progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB/IV Non-Small Cell Lung Cancer
Randomized, Phase III, Placebo-Controlled Trial of Sunitinib as Maintenance Therapy in Non-Progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB/IV Non-Small Cell Lung Cancer
Treatment
Blinded Treatment - will be unblinded at time of progression.
Treatment Arm A: Sunitinib 37.5 mg (three 12.5 mg capsules) orally once daily until disease progression or intolerable toxicity.
Treatment Arm B: Placebo (three capsules) orally once daily intil disease progression or intolerable toxicity.
Blinded Treatment - will be unblinded at time of progression.
Treatment Arm A: Sunitinib 37.5 mg (three 12.5 mg capsules) orally once daily until disease progression or intolerable toxicity.
Treatment Arm B: Placebo (three capsules) orally once daily intil disease progression or intolerable toxicity.
Eligibility
Histologic or cytologic stage IIIB or IV NSCLC. No brain mets or spinal cord compression. Patients must have received 4 cycles of platinum-based doublet therapy with or without bevacizumab. No evidence of disease progression. No prior adjuvant chemo for stage I-III resected or combined modality therapy for stage III NSCLC. Cardiac restrictions apply.
Histologic or cytologic stage IIIB or IV NSCLC. No brain mets or spinal cord compression. Patients must have received 4 cycles of platinum-based doublet therapy with or without bevacizumab. No evidence of disease progression. No prior adjuvant chemo for stage I-III resected or combined modality therapy for stage III NSCLC. Cardiac restrictions apply.
Protocol: Lung - ECOG E1505
Title
A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)
A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)
Treatment
Arm A: 1 of 3 chemotherapy regimens; no bevacizumab
Arm B: 1 of 3 chemotherapy regimens,PLUS bevacizumab 15 mg/kg IV delivered immediately after completion of chemotherapy for the first 4 cycles. Then bevacizumab will continue every 3 weeks for up to 1 year.
Arm A: 1 of 3 chemotherapy regimens; no bevacizumab
Arm B: 1 of 3 chemotherapy regimens,PLUS bevacizumab 15 mg/kg IV delivered immediately after completion of chemotherapy for the first 4 cycles. Then bevacizumab will continue every 3 weeks for up to 1 year.
Eligibility
Complete resection of Stage 1B (>4cm)- IIIA non-small cell lung cancer. Wedge resection or segmentectomy will not be accepted. Lymph node sampling is expected. Refer to protocol for specifics. Patients must be no less than 6 weeks and no more than 12 weeks post-thoracotomy at the time of randomization and must be adequately recovered fom surgery. Performance status 0 or 1. No prior chemo allowed. Hormonal therapy or radiation therapy as prior cancer treatment within 5 years of randomization for a malignancy over 5 years that is now considered cured is acceptable. No myocardial infarction within 12 months. Patients with any history of cerebral vascular accident (CVA) or transient ischemic attack (TIA)will not be allowed on trial. Patients with on-going post-operative hemoptysis are not eligible. Pre-operative hemoptysis that has resolved post-operatively are eligible.
Complete resection of Stage 1B (>4cm)- IIIA non-small cell lung cancer. Wedge resection or segmentectomy will not be accepted. Lymph node sampling is expected. Refer to protocol for specifics. Patients must be no less than 6 weeks and no more than 12 weeks post-thoracotomy at the time of randomization and must be adequately recovered fom surgery. Performance status 0 or 1. No prior chemo allowed. Hormonal therapy or radiation therapy as prior cancer treatment within 5 years of randomization for a malignancy over 5 years that is now considered cured is acceptable. No myocardial infarction within 12 months. Patients with any history of cerebral vascular accident (CVA) or transient ischemic attack (TIA)will not be allowed on trial. Patients with on-going post-operative hemoptysis are not eligible. Pre-operative hemoptysis that has resolved post-operatively are eligible.
Protocol: Lung - S0635
Title
A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma with BAC Features (AdenoBAC)
A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma with BAC Features (AdenoBAC)
Treatment
OSI-774 orally, days 1-21, no pause between cycles and
Bevacizumab IV Day 1, every 21 days.
OSI-774 orally, days 1-21, no pause between cycles and
Bevacizumab IV Day 1, every 21 days.
Eligibility
Biopsy proven incompletely resected or unresectable BAC or BAC variants. Stage IIIB or IV. Measurable or non-measurable disease. Must be willing to provide smoking history. Adequate lab functions. Prior surgery or RT completed 28 days prior. If pallative RT then 14 days must have elapsed and recovered from toxicities. No squamous component. No history of 1/2 tsp hemoptysis within 28 days of registration. No history of stroke, thromboses, or hemmorrhage.
Biopsy proven incompletely resected or unresectable BAC or BAC variants. Stage IIIB or IV. Measurable or non-measurable disease. Must be willing to provide smoking history. Adequate lab functions. Prior surgery or RT completed 28 days prior. If pallative RT then 14 days must have elapsed and recovered from toxicities. No squamous component. No history of 1/2 tsp hemoptysis within 28 days of registration. No history of stroke, thromboses, or hemmorrhage.
Protocol: Lung - SWOG S9925
Title
Lung Cancer Specimen Repository Protocol, Ancillary
Lung Cancer Specimen Repository Protocol, Ancillary
Treatment
Specimen repository.
Specimen repository.
Eligibility
Must be registered to a treatment protocol: S0536; S0424
Must be registered to a treatment protocol: S0536; S0424
Protocol: Lymphoma - SWOG 8947
Title
Central Lymphoma Serum Repository Protocol
Central Lymphoma Serum Repository Protocol
Treatment
Serum repository.
Serum repository.
Eligibility
Must be registered to a treatment protocol.
Must be registered to a treatment protocol.
Protocol: Lymphoma - SWOG 9245
Title
Central Lymphoma Repository Tissue Procurement Protocol for Relapse or Recurrent Disease
Central Lymphoma Repository Tissue Procurement Protocol for Relapse or Recurrent Disease
Treatment
Specimen repository.
Specimen repository.
Eligibility
Must be registered to a treatment protocol: 8410; 8503; 8508; 8516; 8736; 8809; 8907; 8954; 9125; 9240; 9320; 9349; 9432; 9501; 9703; S9704; 9800
Must be registered to a treatment protocol: 8410; 8503; 8508; 8516; 8736; 8809; 8907; 8954; 9125; 9240; 9320; 9349; 9432; 9501; 9703; S9704; 9800
Protocol: Melanoma - S0438
Title
A Randomized Phase II Trial of Bay 43-9006 (Sorafenib; NSC-724772) With Either CCI-779 (Temsirolimus; NSC-683864) or R115777 (Tipifarnib; NSC-702818) in Metastatic Melanoma
A Randomized Phase II Trial of Bay 43-9006 (Sorafenib; NSC-724772) With Either CCI-779 (Temsirolimus; NSC-683864) or R115777 (Tipifarnib; NSC-702818) in Metastatic Melanoma
Treatment
Treatment Arm 1: Bay 43-9006 (sorafenib) orally, twice daily continuously and IV CCI-779 (temsirolimus) given weekly.
Treatment Arm 2: Bay 43-9006 (sorafenib) orally, twice daily continuously and R115777 (tipifarnib) orally, daily for 3 weeks followed by 1 week of rest.
Treatment Arm 1: Bay 43-9006 (sorafenib) orally, twice daily continuously and IV CCI-779 (temsirolimus) given weekly.
Treatment Arm 2: Bay 43-9006 (sorafenib) orally, twice daily continuously and R115777 (tipifarnib) orally, daily for 3 weeks followed by 1 week of rest.
Eligibility
Biopsy proven malignant melanoma of cutaneous or mucosal orgin. Patients with ocular melanoma are not eligible. Patients must have unresectable disease. Patients must have Stage IV disease. Must have measurable disease. Must have negative CT/MRI of brain within 42 days of registration. No prior systemic therapy for Stage IV disease. Prior adjuvant therapy is allowed and may include cytoxic agents, but the interval from most recent exposure until registration must be at least 90 days. Prior RT is allowed if completed at least 28 days prior to registration. Adequate labs.
Biopsy proven malignant melanoma of cutaneous or mucosal orgin. Patients with ocular melanoma are not eligible. Patients must have unresectable disease. Patients must have Stage IV disease. Must have measurable disease. Must have negative CT/MRI of brain within 42 days of registration. No prior systemic therapy for Stage IV disease. Prior adjuvant therapy is allowed and may include cytoxic agents, but the interval from most recent exposure until registration must be at least 90 days. Prior RT is allowed if completed at least 28 days prior to registration. Adequate labs.
Protocol: Melanoma - SWOG E1697
Title
Phase III Randomized Study of Four Weeks High Dose IFN-a2b in Stage T2bNo, T3a-bNo, T4a-bNo, and T1-4, N1a,2a(microscopic) Melanoma
Phase III Randomized Study of Four Weeks High Dose IFN-a2b in Stage T2bNo, T3a-bNo, T4a-bNo, and T1-4, N1a,2a(microscopic) Melanoma
Treatment
Arm A: Observation vs. Arm B: Interferon a2b IV over 20 minutes, five times each week for four weeks.
Arm A: Observation vs. Arm B: Interferon a2b IV over 20 minutes, five times each week for four weeks.
Eligibility
Melanoma of a cutaneous orgin. Stage T2bNo, T3a-bNo, T4a-bNo, and T1-4, N1a,2a,. Patients must complete all primary therapy (wide exicision with or without lymphadenectomy) and be randomized within 84 days of their wide excision. No prior chemotherapy, radiotherapy, or immunotherapy for melanoma allowed.
Melanoma of a cutaneous orgin. Stage T2bNo, T3a-bNo, T4a-bNo, and T1-4, N1a,2a,. Patients must complete all primary therapy (wide exicision with or without lymphadenectomy) and be randomized within 84 days of their wide excision. No prior chemotherapy, radiotherapy, or immunotherapy for melanoma allowed.
Protocol: Prostate - OHSU 2734
Title
A Randomized Phase II Study of Intermittent Chemotherapy or Intermittent Chemotherapy with Maintenance GM-CSF in Patients with Previously Untreated Metastatic Hormone Refractory Prostate Cancer
A Randomized Phase II Study of Intermittent Chemotherapy or Intermittent Chemotherapy with Maintenance GM-CSF in Patients with Previously Untreated Metastatic Hormone Refractory Prostate Cancer
Treatment
Study Enrollment: Induction chemo X 6 cycles Doxetaxel 75 mg IV day 2 + Prednisone 5 mg po bid days 1-21 q 21 days:If there is a decline in PSA by greater than or equal to 50% then Randomization occurs:
Randomization:
Arm 1: Observation-to be evaluated every 28 days, ir progression then reinitiate chemo X 6 cycles: As long as PSA decreases by greater than or equal to 50% patient goes back on observation:
ARM 2: GM-CSF--250mcg/m2 SQ Days 15-28 q 28 days. This continues until progression, once progression occurs reinitiation on chemo X 6 cycles. As long as PSA decreases by greater than or equal to 50% patient goes back on GM-CSF.
After reinitiation of chemo, patient must demonstrate a decrease greater than or equal to 50% AND RECIST-defined stable disease or better.
Study Enrollment: Induction chemo X 6 cycles Doxetaxel 75 mg IV day 2 + Prednisone 5 mg po bid days 1-21 q 21 days:If there is a decline in PSA by greater than or equal to 50% then Randomization occurs:
Randomization:
Arm 1: Observation-to be evaluated every 28 days, ir progression then reinitiate chemo X 6 cycles: As long as PSA decreases by greater than or equal to 50% patient goes back on observation:
ARM 2: GM-CSF--250mcg/m2 SQ Days 15-28 q 28 days. This continues until progression, once progression occurs reinitiation on chemo X 6 cycles. As long as PSA decreases by greater than or equal to 50% patient goes back on GM-CSF.
After reinitiation of chemo, patient must demonstrate a decrease greater than or equal to 50% AND RECIST-defined stable disease or better.
Eligibility
Previously Untreated Metastatic Hormone Refractory Prostate Cancer
Previously Untreated Metastatic Hormone Refractory Prostate Cancer
Protocol: Prostate - RTOG 0521
Title
Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT vs AS and 3DCRT/IMRT followed by Chemotherapy with Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer
Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT vs AS and 3DCRT/IMRT followed by Chemotherapy with Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer
Treatment
Treatment Arm 1: AS (LHRH agonist and oral antiandrogen) X 8 weeks followed by Radiation Therapy to 72.0 - 75.0 Gy with concurrent AS. LHRH will continue for a total of 24 months from initiation of any treatment. Oral antiandrogen will be discontinued at the end of radiotherapy.
Treatment Arm 2: AS (LHRH agonist and oral antiandrogen) X 8 weeks followed by Radiation Therapy to 72.0 - 75.0 Gy with concurrent AS. LHRH will continue for a total of 24 months from initiation of any treatment. Oral antiandrogen will be discontinued at the end of RT. PLUS 6 cycles of docetaxel and prednisone delivered concurrently with androgen suppression beginning 28 days after completion of RT: Docetaxel IV over 1 hour on day 1 of each cycle every 21 days. Premedication for docetaxel with dexamethasone is required. PLUS Oral Prednisone daily until day 21 of the last cycle of chemotherapy.
Treatment Arm 1: AS (LHRH agonist and oral antiandrogen) X 8 weeks followed by Radiation Therapy to 72.0 - 75.0 Gy with concurrent AS. LHRH will continue for a total of 24 months from initiation of any treatment. Oral antiandrogen will be discontinued at the end of radiotherapy.
Treatment Arm 2: AS (LHRH agonist and oral antiandrogen) X 8 weeks followed by Radiation Therapy to 72.0 - 75.0 Gy with concurrent AS. LHRH will continue for a total of 24 months from initiation of any treatment. Oral antiandrogen will be discontinued at the end of RT. PLUS 6 cycles of docetaxel and prednisone delivered concurrently with androgen suppression beginning 28 days after completion of RT: Docetaxel IV over 1 hour on day 1 of each cycle every 21 days. Premedication for docetaxel with dexamethasone is required. PLUS Oral Prednisone daily until day 21 of the last cycle of chemotherapy.
Eligibility
Histologically confirmed prostate cancer within 180 days prior to registration. Pretreatment serum PSA obtained prior to any LHRH or antiandrogen therapy. Prior 5-alpha reductase inhibitor (finasteride) for prostatic hypertrophy is allowed if discontinued at least 60 days prior to registration. Prior testosterone administration is allowed if last administered at least 90 days prior to registration. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation is < = 50 days prior to the date of registration. INELIGIBILTY: PSA > 150. Evidence of M1 disease. Positive lymph nodes or nodes > 1.5 cm on imaging. Prior radical prostatectomy, cryosurgery, bilateral orchiectomy, malignancy, systemic chemotherapy, radiotherapy including brachytherapy within current treatment field. Severe, active co-morbidity such as unstable angina or CHF requiring hospitalization with the last 6 months. Prior MI with the last 6 months. Existing neuropathy > grade 2.
Histologically confirmed prostate cancer within 180 days prior to registration. Pretreatment serum PSA obtained prior to any LHRH or antiandrogen therapy. Prior 5-alpha reductase inhibitor (finasteride) for prostatic hypertrophy is allowed if discontinued at least 60 days prior to registration. Prior testosterone administration is allowed if last administered at least 90 days prior to registration. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation is < = 50 days prior to the date of registration. INELIGIBILTY: PSA > 150. Evidence of M1 disease. Positive lymph nodes or nodes > 1.5 cm on imaging. Prior radical prostatectomy, cryosurgery, bilateral orchiectomy, malignancy, systemic chemotherapy, radiotherapy including brachytherapy within current treatment field. Severe, active co-morbidity such as unstable angina or CHF requiring hospitalization with the last 6 months. Prior MI with the last 6 months. Existing neuropathy > grade 2.
Protocol: Prostate - RTOG 0534
Title
A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (Spport) in Prostate Cancer Patients with a Rising PSA after Radical Prostatectomy
A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (Spport) in Prostate Cancer Patients with a Rising PSA after Radical Prostatectomy
Treatment
Arm 1: PBRT Alone at 64.8-70.2 Gy
Arm 2: PBRT + NC-STAD for 4-6 months, beginning 2 months before RT
Arm 3: PLNRT to 45 Gy and PBRT to 64.8-70.2 Gy, NC-STAD for 4-6 months, beginning 2 months before RT
PBRT= prostate bed RT; PLNRT=pelvic lymph node RT; NC-STAD= neoadjuvant and concurrent short term androgen deprivation
Arm 1: PBRT Alone at 64.8-70.2 Gy
Arm 2: PBRT + NC-STAD for 4-6 months, beginning 2 months before RT
Arm 3: PLNRT to 45 Gy and PBRT to 64.8-70.2 Gy, NC-STAD for 4-6 months, beginning 2 months before RT
PBRT= prostate bed RT; PLNRT=pelvic lymph node RT; NC-STAD= neoadjuvant and concurrent short term androgen deprivation
Eligibility
Adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to be lymph node negative by pelvic lymphadenectomy (NO) or lymph node status pathologically unknown (undissected pelvic lymph nodes); Post radical prostatectomy entry PSA => 0.2 and =<2.0 ng/ml at least 6 weeks after prostatectomy and within 30 days of registration; Must be T3N0/NX, T2NO/NX with positive prostatectomy margin and/or positive prostatic fossa; or urethral-vesical anastomosis biopsies; Gleason score of 8 or less; PSA doubling time of > 6 months; No distant mets allowed; Adequate lab values; No N1 disease.
Adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to be lymph node negative by pelvic lymphadenectomy (NO) or lymph node status pathologically unknown (undissected pelvic lymph nodes); Post radical prostatectomy entry PSA => 0.2 and =<2.0 ng/ml at least 6 weeks after prostatectomy and within 30 days of registration; Must be T3N0/NX, T2NO/NX with positive prostatectomy margin and/or positive prostatic fossa; or urethral-vesical anastomosis biopsies; Gleason score of 8 or less; PSA doubling time of > 6 months; No distant mets allowed; Adequate lab values; No N1 disease.
Protocol: Renal - E2805
Title
Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
Treatment
Treatment Arm A: Sunitinib 50mg orally daily for 4 weeks followed by 2 weeks of rest for 9 cycles AND placebo for Sunitinib 400mg orally twice daily for 6 weeks for 9 cycles.
Treatment Arm B: Sorafenib 400mg orally twice daily for 6 weeks for 9 cycles AND Placebo for Sunitinib 50mg orally daily for 4 weeks followed by 2 weeks of rest for 9 cycles.
Treatment Arm C: Placebo for Sorafenib 400mg orally twice daily for 6 weeks for 9 cycles AND Placebo for Sunitinib 50mg orally daily for 4 weeks followed by 2 weeks of rest for 9 cycles.
Treatment Arm A: Sunitinib 50mg orally daily for 4 weeks followed by 2 weeks of rest for 9 cycles AND placebo for Sunitinib 400mg orally twice daily for 6 weeks for 9 cycles.
Treatment Arm B: Sorafenib 400mg orally twice daily for 6 weeks for 9 cycles AND Placebo for Sunitinib 50mg orally daily for 4 weeks followed by 2 weeks of rest for 9 cycles.
Treatment Arm C: Placebo for Sorafenib 400mg orally twice daily for 6 weeks for 9 cycles AND Placebo for Sunitinib 50mg orally daily for 4 weeks followed by 2 weeks of rest for 9 cycles.
Eligibility
Patients with histological or cytological confirmed RCC T1B, T2, T3 and T4 with any N. Patients must have undergone full surgical resection - radical or partial nephrectomy by either open or laparoscopic technique, with clear margins. Positive regional LNs require regional lymphadenectomy. Patients must not have CT or MRI evidence of residual or metastatic disease. Must have tumor specimen available for specimen submission. Must not have collecting duct or medullary carcinoma. No prior anticancer treatments for RCC either in the adjuvant or neoadjuvant setting. Patients must be 3-10 weeks post surgery at randomization in order to begin protocol treatment 4-12 weeks from surgery.
Patients with histological or cytological confirmed RCC T1B, T2, T3 and T4 with any N. Patients must have undergone full surgical resection - radical or partial nephrectomy by either open or laparoscopic technique, with clear margins. Positive regional LNs require regional lymphadenectomy. Patients must not have CT or MRI evidence of residual or metastatic disease. Must have tumor specimen available for specimen submission. Must not have collecting duct or medullary carcinoma. No prior anticancer treatments for RCC either in the adjuvant or neoadjuvant setting. Patients must be 3-10 weeks post surgery at randomization in order to begin protocol treatment 4-12 weeks from surgery.
Protocol: Renal - OHSU 2683
Title
A Dose-Escalation Phase II Study of Sunitinib plus Erlotinib in Advanced Renal Carcinoma
A Dose-Escalation Phase II Study of Sunitinib plus Erlotinib in Advanced Renal Carcinoma
Treatment
Erlotinib 150mg a day, continuous daily; Sunitinib 50mg a day - 4 weeks on, 2 weeks off.
Erlotinib 150mg a day, continuous daily; Sunitinib 50mg a day - 4 weeks on, 2 weeks off.
Eligibility
Histologic diagnosis of RCC with a component of clear cell or papillary carcinoma. RCC histology without any component of clear cell or papilary is not eligible. Patients must have radiographic or clinical evidence of mets or unresectable disease. Prior nephrectomy is not required. At least one measurable site of disease by RECIST criteria. P. Status 0,1,2. Adequate organ function.
Histologic diagnosis of RCC with a component of clear cell or papillary carcinoma. RCC histology without any component of clear cell or papilary is not eligible. Patients must have radiographic or clinical evidence of mets or unresectable disease. Prior nephrectomy is not required. At least one measurable site of disease by RECIST criteria. P. Status 0,1,2. Adequate organ function.
Last Updated: January 6, 2009