Sorafenib, Gemcitabine, and Capecitabine in Treating Patients With Unresectable and/or Metastatic Kidney Cancer
Recurrent Renal Cell Carcinoma
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Drug: Gemcitabine Hydrochloride
Drug: Sorafenib Tosylate
|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.
- Overall survival [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
- 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.
|Study Start Date:||April 2005|
|Estimated Primary Completion Date:||July 2016 (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.
Other Names:Drug: Gemcitabine Hydrochloride
Other Names:Drug: Sorafenib Tosylate
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121251
|United States, New York|
|Montefiore Medical Center - Moses Campus|
|Bronx, New York, United States, 10467-2490|
|Mount Sinai Medical Center|
|New York, New York, United States, 10029|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10065|
|Principal Investigator:||Scott Tagawa||Montefiore Medical Center - Moses Campus|