Sorafenib, Gemcitabine, and Capecitabine in Treating Patients With Unresectable and/or Metastatic Kidney Cancer
This phase I/II trial is studying the side effects and best dose of sorafenib, gemcitabine, and capecitabine and to see how well they work in treating patients with unresectable and/or metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with gemcitabine and capecitabine may kill more tumor cells
Recurrent Renal Cell Cancer
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Drug: sorafenib tosylate
Drug: gemcitabine hydrochloride
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Trial of BAY 43-9006 Plus Gemcitabine and Capecitabine in the Treatment of Patients With Advanced Renal Cell Carcinoma|
- Objective response for BAY 43-9006 in combination with gemcitabine and capecitabine evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]This design yields at least 90% power to detect a true response rate of at least 30%. If at least 6 responses were observed among the 35 evaluable patients, this regimen would be considered worthy of further testing in this disease.
- Progression-free survival evaluated by the RECIST [ Time Frame: From the time of the patient's initial best response (PR or CR) until documented progression, assessed up to 9 years ] [ Designated as safety issue: No ]PFS > 3 months is suggestive of a durable benefit from the treatment.
- Overall survival [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive sorafenib* PO BID on days 1-21, gemcitabine IV over 30 minutes on days 1 and 8, and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for at least 3 courses in the absence of unacceptable toxicity or disease progression.
Drug: sorafenib tosylate
Other Names:Drug: gemcitabine hydrochloride
Other Names:Drug: capecitabine
I. Determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of sorafenib administered in combination with gemictabine and capecitabine in patients with advanced renal cell carcinoma.
II. Determine the objective response rate for sorafenib in combination with gemictabine and capecitabine in patients with advanced renal cell carcinoma.
III. Determine the duration of overall survival and progression free survival in these patients.
OUTLINE: This is a multicenter, non-randomized, phase I dose-escalation study followed by a phase II study.
PHASE I: Patients receive sorafenib* orally (PO) twice daily (BID) on days 1-21, gemcitabine intravenously (IV) over 30 minutes on days 1 and 8, and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for at least 3 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of sorafenib, gemcitabine, and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.
Note: *Patients who complete at least 3 courses of treatment with objective response or stable disease but are deemed poor candidates for continued chemotherapy may continue treatment with sorafenib
PHASE II: Patients receive sorafenib, gemcitabine, and capecitabine as in phase I at the MTD determined in phase I.
After completion of study treatment patients are followed periodically.
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467-2490|
|Principal Investigator:||Scott Tagawa||Montefiore Medical Center|