Renal Cell Carcinoma Clinical Trials

March 7, 2011

Here are descriptions of three clinical trials that are currently recruiting patients with renal cell caricinoma.

Renal Cell Carcinoma (RCC) is the most common type of kidney cancer in adults. The following 3 summaries describe clinical trials that are currently recruiting patients with RCC.

Bevacizumab with or without sunitinib in sunitinib-refractory renal cell carcinoma

Study Type: Interventional

Age/Sex Requirements: >18 years

Sponsor: Massachusetts General Hospital

ClinicalTrials.gov Identifier: NCT00556205

Purpose: This study will be testing bevacizumab (Avastin), a drug approved by the FDA for several cancers, with or without sunitinib, a drug that has been approved for RCC, in the treatment of RCC that is refractory to sunitinib. Participants in the study will be randomized into 2 groups. One group will receive bevacizumab alone intravenously every 14 days while the other group receives bevacizumab as well as sunitinib orally once daily. The primary outcome measure is the time to tumor progression. Secondary outcome measures include the overall response rate and the safety and tolerability of these treatments in RCC patients with disease progression on standard dose sunitinib. The researchers will also be collecting serum research samples for analysis of predictive biomarkers of response. http://bit.ly/bEQWlE

Velcade and sorafenib in unresected or metastatic renal cell carcinoma

Study Type: Interventional

Ag e/Sex Requirements: 18 years

Sponsor: New Mexico Cancer Care Alliance

ClinicalTrials.gov Identifier: NCT01100242

P urpose: This phase II open-label, non-randomized, single-arm study will assess the safety and efficacy of combination treatment with sorafenib (Nexavar) and Velcade (bortezomib) in patients with unresected or metastatic RCC. The primary outcome measure of this clinical trial is progression-free survival (PFS). Secondary endpoints include toxicity and response rate. The trial is taking place at the University of New Mexico Cancer Center. http://bit.ly/bkI7fZ

Capecitabine, gemcitabine, and bevacizumab in combination for patients with sarcomatoid renal cell carcinoma

Study Type: Interventional

Age/Sex Requirements: None

Sponsor: MD Anderson Cancer Center

ClinicalTrials.gov Identifier: NCT00496587

Purpose: This phase II open-label, non-randomized, interventional, single-arm trial will evaluate the safety and efficacy of combination treatment with capecitabine (Xeloda), gemcitabine (Gemzar), and bevacizumab in patients with metastatic or unresectable RCC with sarcomatoid features. Gemcitabine and capecitabine obstruct cancer cell growth and bevacizumab inhibits Vascular Endothelial Growth Factor (VEGF). The primary outcome measure of this clinical trial is PFS. Secondary outcome measures for the study are overall survival, response rates, and toxicity. Participants will receive treatment on a 28-day cycle. Capecitabine (800 mg/m2) will be administered twice daily on days 1-21. Patients will take 900 mg/m2 of gemcitabine and 10 mg/kg of bevacizumab on days 1 and 15. http://bit.ly/dtj7ku