Phase II, Single Arm Trial of Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma
- 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
- Gemcitabine will be given intravenously at the study clinic on days 1 and 8 of each
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the overall response rate of combination therapy with gemcitabine and sunitinib in sarcomatoid and/or poor-risk mRCC patients as first line therapy.
Until disease progression
M. Dror Michaelson, MD, PhD
Massachusetts General Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Beth Israel Deaconess Medical Center`||Boston, Massachusetts 02115|