Sorafenib, Gemcitabine, and Capecitabine in Treating Patients With Unresectable and/or Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00121251|
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : May 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Renal Cell Carcinoma Stage III Renal Cell Cancer AJCC v7 Stage IV Renal Cell Cancer AJCC v7||Drug: Capecitabine Drug: Gemcitabine Hydrochloride Drug: Sorafenib Tosylate||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 19, 2005|
|Actual Primary Completion Date :||March 14, 2017|
|Actual Study Completion Date :||March 14, 2017|
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: Gemcitabine Hydrochloride
Drug: Sorafenib Tosylate
- 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 ]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 ]PFS > 3 months is suggestive of a durable benefit from the treatment.
- Overall survival [ Time Frame: Up to 9 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121251
|United States, New York|
|Montefiore Medical Center - Moses Campus|
|Bronx, New York, United States, 10467|
|Laura and Isaac Perlmutter Cancer Center at NYU Langone|
|New York, New York, United States, 10016|
|Mount Sinai Hospital|
|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|