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

Conditions

• Clear Cell Renal Cell Carcinoma
• Recurrent Renal Cell Carcinoma
• Stage IV Renal Cell Cancer AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Pharmacological Study — OTHER
  Correlative studies
• Sorafenib Tosylate — DRUG
  Given PO
• Temsirolimus — DRUG
  Given IV

Study Details

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 Dates

First listed

Sep 21, 2006

Start date

Sep 14, 2007

Status verified

Oct 2018

Primary completion

Feb 7, 2014

Completion

Mar 21, 2017

Study Design

Enrollment

361 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (bevacizumab)
  Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15.
• Experimental: Arm B (bevacizumab and temsirolimus)
  Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A.
• Experimental: Arm C (bevacizumab and sorafenib tosylate)
  Patients receive bevacizumab as in Arm A and sorafenib tosylate PO BID on days 1-5, 8-12, 15-19, and 22-26.
• Experimental: Arm D (sorafenib tosylate and temsirolimus)
  Patients receive sorafenib tosylate PO BID on days 1-28 and temsirolimus as in Arm B.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years ]

Locations (558)

Find similar trials in Birmingham, AL

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