Bevacizumab, Sorafenib Tosylate, and Temsirolimus in Treating Patients With Metastatic Kidney Cancer

Completed · Phase 2

Conditions studied: Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v7

In brief

This randomized phase II trial studies different combinations of bevacizumab, temsirolimus, and sorafenib tosylate to see how well they work compared with bevacizumab alone in treating patients with kidney cancer that has spread to other places in the body. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab and sorafenib tosylate may stop the growth of tumor cells by blocking blood flow to the tumor. Temsirolimus and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving different combinations of bevacizumab, sorafenib tosylate, and temsirolimus may be more effective than bevacizumab alone in treating metastatic kidney cancer.

Key facts

Study ID

NCT00378703

Run by

National Cancer Institute (NCI)

People needed

361

Starts

2007-09-14

Expected to finish

2017-03-21

Last updated by the study team

2018-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients will be required to have the clear cell variant of renal cell carcinoma with less than 25% of any other histology (including, but not limited to, papillary or chromophobe or oncocytic); there must be histologic confirmation by treating center of either primary or metastatic lesion
• Patients will be required to have measurable metastatic disease that is not curable by standard radiation therapy or surgery; all sites must be assessed within 4 weeks prior to study entry
• Previous nephrectomy is required with the following exceptions:
• Primary tumor =< 5 cm, or
• Extensive liver (> 30% of liver parenchymal) or multiple (> 5) bone metastases, making nephrectomy a clinically questionable procedure
• Unresectable primary tumor due to invasion into adjacent organs or encasing the aorta or vena cava
• No prior cytotoxic chemotherapy; a maximum of one prior regimen of either vaccine or cytokine-based immunotherapy disease is permitted
• No prior anti-angiogenic therapy including, but not limited to, SU11248, ZD6474 or VEGF Trap; no prior therapy with bevacizumab, mammalian target of rapamycin (mTOR) inhibitors (including, but not limited to, temsirolimus), or sorafenib will be allowed; thalidomide or interferon alpha (IFNalpha) are allowed either for adjuvant therapy or stage IV disease
• No immunotherapy within 4 weeks of randomization; toxicities from immunotherapy must have resolved and a minimum of two weeks must pass prior to enrollment
• Prior radiation therapy is permitted, but toxicities from radiation must have resolved and a minimum of 2 weeks must pass prior to randomization
• No history or clinical evidence of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastasis, or history of stroke within the past 48 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy of greater than 12 weeks
• Hemoglobin (Hgb) >= 9.0 g/dL (transfusions allowed prior to enrollment)
• White blood count (WBC) >= 3,000/mm\^3
• Absolute granulocyte count (AGC) >= 1,200/mm\^3
• Platelet count >= 100,000/mm\^3
• Serum creatinine =< 1.5 x upper limit of normal (ULN) or serum creatinine clearance (CrCl) >= 55 ml/min
• Total bilirubin =< 1.5 x ULN
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN (or =< 5.0 x ULN in the presence of liver metastases)
• International normalized ratio (INR) =< 1.5
• Activated partial thromboplastin time (aPTT) within normal limits
• Fasting cholesterol < 350 mg/dL (9.0 mmol/L)
• Fasting triglycerides < 400 mg/dL (4.56 mmol/L)
• Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, and ductal or lobular carcinoma in situ of the breast; patients with other malignancies are eligible if they have been continuously disease-free for >= 5 years prior to the time of randomization

Where it is running

• Providence Hospital — Mobile, Alabama, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• The University of Arizona Medical Center-University Campus — Tucson, Arizona, United States
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
• NEA Baptist Memorial Hospital — Jonesboro, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• Mills-Peninsula Medical Center — Burlingame, California, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• Valley Medical Oncology Consultants-Castro Valley — Castro Valley, California, United States
• Bay Area Breast Surgeons Inc — Emeryville, California, United States
• Valley Medical Oncology Consultants-Fremont — Fremont, California, United States
• Glendale Memorial Hospital and Health Center — Glendale, California, United States
• Marin Cancer Care Inc — Greenbrae, California, United States
• Marin General Hospital — Greenbrae, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• Fremont - Rideout Cancer Center — Marysville, California, United States
• El Camino Hospital — Mountain View, California, United States
• Palo Alto Medical Foundation-Camino Division — Mountain View, California, United States
• Sutter Cancer Research Consortium — Novato, California, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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