NCT00556049

Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma

Phase II, Single Arm Trial of Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine if the combination of sunitinib and gemcitabine is effective in treating patients with metastatic renal cell carcinoma. The safety of this combination will also be studied. Sunitinib is approved by the FDA for the treatment of renal cell carcinoma. However, some patients' cancers do not respond to treatment or stops responding after initially responding. Gemcitabine is a chemotherapy drug that is approved by the FDA for the treatment of pancreatic cancer and several other cancers. It is not approved for the treatment of renal cell carcinoma. Previous research has suggested that combining gemcitabine with sunitinib may have some effectiveness in treating metastatic renal cell carcinoma.

Detailed description

* Participants will receive study treatment as an outpatient. Study treatment will be given in 3-week cycles. * Sunitinib will be taken orally once per day for the first two weeks (days 1-14) of each treatment cycle. * Gemcitabine will be given intravenously at the study clinic on days 1 and 8 of each treatment cycle. * Before receiving sunitinib and gemcitabine on day 1 of each cycle the following will be performed: physical exam, performance status assessment and blood work. Before receiving gemcitabine on day 8 the following will be performed: physical exam, performance status assessment and blood work. Every 3 cycles a CT scan will be performed to measure the tumor.

Conditions

• Renal Cell Carcinoma
• Neoplasm Metastases

Interventions

Type	Name	Description
DRUG	Gemcitabine	Intravenously on days 1 and 8 of each 21-day treatment cycle.
DRUG	Sunitinib	Orally on days 1-14 of each 21-day treatment cycle

Timeline

• Start date: 2007-12-01
• Primary completion: 2013-12-01
• Completion: 2014-12-01
• First posted: 2007-11-09
• Last updated: 2016-04-21
• Results posted: 2015-04-03

Locations

3 sites across 1 country: United States