RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sunitinib malate and gemcitabine hydrochloride together is more effective than sunitinib malate alone in treating patients with kidney cancer. PURPOSE: This randomized phase II clinical trial is studying giving sunitinib malate together with or without gemcitabine hydrochloride to see how well they work in treating patients with advanced kidney cancer that cannot be removed by surgery.
OBJECTIVES: Primary * To evaluate the response rate to sunitinib malate with vs without gemcitabine hydrochloride in patients with advanced renal cell carcinoma with sarcomatoid features. Secondary * To evaluate progression-free survival of these patients. * To evaluate overall survival of these patients. * To describe the toxic effects of both sunitinib malate alone and in combination with gemcitabine hydrochloride in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to risk (good risk \[clear cell and \< 20% sarcomatoid and performance status (PS) 0\] vs intermediate risk \[20-50% sarcomatoid and PS 0\] vs poor risk \[non-clear cell or \> 50% sarcomatoid or PS 1 or non-clear cell\]). Patients are randomized to 1 of 2 treatment arms. * Arm A: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. * Arm B: Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. In both arms, courses repeat every 42 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year. ACTUAL ACCRUAL: A total of 87 patients (47 in arm A and 40 in arm B) were accrued to this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Given IV
Given PO
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Stanford Cancer Center
Stanford, California, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States
Proportion of Patients With Response
Response is defined as either complete response (CR, disappearance of all lesions) or partial response (PR, at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits).
Time frame: Assessed every 3 months for 2 years and every 6 months for year 3.
Progression-free Survival
Progression-free survival is defined as the time from randomization to progression or death, whichever occurs first. Progression is defined as follows: * At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. * Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Assessed every 3 months for 2 years and every 6 months for year 3.
Overall Survival
Overall survival is defined as the time from randomization to death or date last known alive.
Time frame: Assessed every 3 months for 2 years and every 6 months for year 3.
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CCOP - Christiana Care Health Services
Newark, Delaware, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
St. Joseph Medical Center
Bloomington, Illinois, United States
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