Trial of Gemcitabine, Carboplatin, and Sorafenib in Chemotherapy-naive Patients With Advanced/Metastatic Bladder Carcinoma
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|ClinicalTrials.gov Identifier: NCT00461851|
Recruitment Status : Completed
First Posted : April 18, 2007
Results First Posted : November 1, 2016
Last Update Posted : December 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: Gemcitabine Drug: Carboplatin Drug: Sorafenib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Multicenter Trial of Gemcitabine, Carboplatin, and Sorafenib in Chemotherapy-naive Patients With Advanced/Metastatic Bladder Carcinoma|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Experimental: Chemotherapy plus sorafenib
Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone
Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.
Other Name: GemzarDrug: Carboplatin
Carboplatin will be given on day 1 to an AUC of 5.Drug: Sorafenib
Sorafenib will be administered orally daily on days 2-19 at 400 mg bid
Other Name: BAY 43-9006
- Progression Free Survival (PFS) [ Time Frame: Upon completion of study ]The primary outcome was the proportion of patients who achieved progression free survival (PFS) of five months. PFS was defined as time to progression or any-cause mortality, whichever came first.
- Dose Ruction (Toxicity) [ Time Frame: Upon completion of study ]To determine the toxicity of combination therapy with sorafenib, gemcitabine and carboplatin, dose reductions by drug are reported. The number of patients that were reduced in dosage are reported here.
- Best Reported Response [ Time Frame: Upon completion of study ]The best reported response captures the proportion of patients with advanced or metastatic transitional cell carcinoma of the bladder that achieve a complete or partial response to the combination therapy with sorafenib, gemcitabine, and carboplatin.
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): NCT00461851
|United States, Connecticut|
|Yale University, Comprehensive Cancer Center|
|New Haven, Connecticut, United States, 06520|
|Principal Investigator:||Hari Deshpande, MD||Yale University|