Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery
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.
|Kidney Cancer||Drug: gemcitabine hydrochloride Drug: sunitinib malate||Phase 2|
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma With Sarcomatoid Features|
- Response rate
- Progression-free survival
- Overall survival
|Study Start Date:||June 2010|
|Estimated Primary Completion Date:||June 2021 (Final data collection date for primary outcome measure)|
Experimental: Arm I
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.
Drug: gemcitabine hydrochloride
Given IVDrug: sunitinib malate
Active Comparator: Arm II
Patients receive oral sunitinib malate once daily on days 1-14 and 22-35.
Drug: sunitinib malate
- To evaluate the response rate to sunitinib malate with vs without gemcitabine hydrochloride in patients with advanced renal cell carcinoma with sarcomatoid features.
- 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 I: 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 II: 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.
PROJECTED ACCRUAL: A total of 100 patients (60 in arm I and 40 in arm II) will be accrued to this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164228
Show 99 Study Locations
|Principal Investigator:||Naomi S. Balzer-Haas, MD||Abramson Cancer Center of the University of Pennsylvania|