Conditions: Renal Cell Carcinoma Neoplasm Metastases
Keywords: mRCC sunitinib gemcitabine
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 72
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Sunitinib and gemcitabine

Interventions: intervention 1: Gemcitabine intervention 2: Sunitinib
Intervention descriptions: intervention 1: Intravenously on days 1 and 8 of each 21-day treatment cycle. intervention 2: Orally on days 1-14 of each 21-day treatment cycle

Protocol document: