Renal Cancer Treatment Trials
Superiority of Axitinib (AG-013736) to Sorafenib in delaying tumor progression in patients with metastatic (spreading) renal cell cancer (SLHN 2008-49; Pfizer A4061032 Renal)
Purpose
The study is designed to show that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic (spreading) renal cell cancer after failure of one initial regimen.
Eligibility Criteria
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Confirmed renal cell cancer that has spread to other parts of the body
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Disease that can be measured on a scan or X-ray
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Must have had one prior treatment for metastatic renal cell cancer that has failed
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It has been more than 4 weeks since major surgery or more than 2 weeks since radiation before starting study drug
Final eligibility is determined by the research staff.
Bevacizumab and RAD001 compared to Bevacizumab and Interferon alfa-2a for initial treatment of kidney cancer (SLHN 2008-51; Novartis RAD001 CRAD001L2201 Kidney)
Purpose
The purpose of this study is to find the difference in results and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for initial treatment of patients with metastatic carcinoma of the kidney.
Eligibility Criteria
- Confirmed metastatic renal cell carcinoma
- At least one tumor measurable by an X-ray or scan
- Prior partial or complete nephrectomy (surgical removal of a kidney)
- Must be greater than 4 weeks post-major surgery
- Last radiation therapy must be 29 days or more prior to start of study
- No prior treatment for metastatic disease
- No untreated brain metastases
- No inadequately controlled high blood pressure
- No history of another cancer 3 years or less
Final eligibility is determined by the research staff.
A randomized, double-blind phase III trial of adjuvant Sunitinib versus Sorafenib versus placebo in patients with resected renal cell carcinoma (E2805)
Purpose
Sunitinib and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib or sorafenib after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib is more effective than sorafenib or placebo in treating kidney cancer.
This randomized phase III trial is studying sunitinib to see how well it works compared to sorafenib or placebo in treating patients with kidney cancer that has been removed by surgery.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- Has undergone surgery to remove the kidney within the past 3-10 weeks or planning to undergo surgery to remove the kidney
- Planning to start study treatment four to 12 weeks after surgery to remove the kidney
- No spread of cancer to other parts of the body
- No previous treatment for cancer other than surgery
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients who have not undergone surgery to remove the tumor will undergo nephrectomy. Patients will then be randomly assigned (have an equal chance of being placed) to one of three treatment groups.
- Patients in group one will receive sunitinib by mouth once-a-day for four weeks and a placebo by mouth twice-a-day for six weeks. Treatment may repeat every six weeks for up to nine courses.
- Patients in group two will receive sorafenib by mouth twice-a-day for six weeks and a placebo by mouth once a day for four weeks. Treatment may repeat every six weeks for up to nine courses.
- Patients in group three will receive one placebo by mouth twice-a-day for six weeks and another placebo by mouth once-a-day for four weeks. Treatment may repeat every six weeks for up to nine courses.
Patients will undergo tumor tissue collection before and during surgery. Patients will also undergo blood and urine sample collection periodically for laboratory studies.
After finishing treatment, patients will be evaluated periodically for nine years.
Two different doses of VEGF Trap to see/compare how well they work in treating patients with metastatic or unresectable kidney cancer (E4805)
Purpose
VEGF Trap may stop the growth of kidney cancer by blocking blood flow to the tumor.
This randomized phase II trial is studying two different doses of VEGF Trap to see compare well they work in treating patients with metastatic or unresectable kidney cancer.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- Received no more than one previous treatment with sunitinib or sorafenib for at least three months
- Disease that has progressed
- Spread of cancer to the brain or spinal cord
- No previous chemotherapy, vaccine therapy, or hormone therapy
- More than three weeks since radiation therapy
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
- Patients in group one will receive a one-hour infusion of low-dose VEGF Trap. Treatment may repeat every two weeks for as long as benefit is shown. After four courses, some patients may receive treatment as in group two.
- Patients in group two will receive a one-hour infusion of high-dose VEGF Trap. Treatment may repeat every two weeks for as long as benefit is shown.
After finishing treatment, patients will be evaluated every three months for three years.
Phase II Randomized Study of Bevacizumab, Sorafenib Tosylate, and Temsirolimus in Patients With Metastatic Renal Cell Carcinoma (E2804)
Purpose
Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab and sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor. Temsirolimus and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving different combinations of bevacizumab, sorfenib, and temsirolimus may be more effective than bevacizumab alone in treating metastatic kidney cancer.
This randomized phase II trial is studying different combinations of bevacizumab, temsirolimus, and sorafenib to see how well they work compared with bevacizumab alone in treating patients with metastatic kidney cancer.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- Disease that can be measured on a scan or X-ray
- No cancer of the brain or spinal column
- No previous sunitinib, ZD6474, or VEGF Trap
- No previous bevacizumab, temsirolimus, or sorafenib
- More than four weeks since biological therapy, surgery, or open biopsy
- More than two weeks since radiation therapy
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned (have an equal chance of being placed) to one of four treatment groups.
- Patients in group one will receive a 30- to 90-minute infusion of bevacizumab once in weeks 1 and 3.
- Patients in group two will receive an infusion of temsirolimus once a week for 4 weeks. They will also receive a 30- to 90-minute infusion of bevacizumab once in weeks 1 and 3.
- Patients in group three will receive a 30- to 90-minute infusion of bevacizumab once in weeks 1 and 3. They will also receive sorafenib by mouth twice a day for 4 weeks.
- Patients in group four will receive an infusion of temsirolimus once a week for 4 weeks. They will also receive sorafenib by mouth twice a day for 4 weeks.
Treatment in all groups may repeat every 4 weeks for as long as benefit is shown. After finishing treatment, patients will be evaluated periodically for five years.