E1808 A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma with Sarcomatoid Features
To evaluate how well people respond to a combination of sunitinib and gemcitabine versus sunitinib alone in those with advanced renal cell cancer with sarcomatoid features.
must be at least 18 years of age, must have measurable advanced disease that is not resectable by surgery, no prior systemic therapy for metastatic disease, must have good heart function, no history or evidence of brain disease, must be in good physical condition, must be HIV negative, must have good blood, liver and kidney function
People will be randomized into 1 of 2 arms of treatment. Arm A will receive gemcitabine and sunitinib malate. Gemcitabine will be given through an IV catheter over 30 minutes 4 times in a 6 week (42 day) cycle (on days 1, 8, 22 and 29 of each cycle) in combination with Sunitinib 37.5 mg once daily on days 1-14 and days 22-35 of each cycle. There will be a one week (7 day) break from sunitinib taking place on days 15-21 and an additional one week break on days 36-42 of each cycle. Arm B will receive Sunitinib 50 mg once daily (days 1-14 and days 22-35 of each cycle). There will be a one week (7 day) break from sunitinib taking place on days 15-21 and an additional one week break on days 36-42 of each cycle. Each cycle is 42 days (6 weeks.) Treatment should be repeated for a total of 1 year. Blood work will be done at every clinic visit and scans will be done every 2 cycles.
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