Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naive to Systemic Therapy
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|ClinicalTrials.gov Identifier: NCT00919061|
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
The purpose of this study is to test an investigational combination of drugs for bile duct or gallbladder cancers.
Gemcitabine and cisplatin are two forms of chemotherapy commonly used in combination to treat bile duct and gallbladder cancers. We are looking to improve treatment results. We will attempt to do so by adding sorafenib (a type of monoclonal antibody) to your treatment plan. Sorafenib acts by attaching to blocking specific targets on cells. These targets may help the cancer cells grow and divide. This study will help answer the question of whether sorafenib is a helpful drug in patients with bile duct or gallbladder cancers when given with gemcitabine and cisplatin.
This study is a phase 2 study. The purpose of a phase 2 study is to find out what effects, good and/or bad, sorafenib in combination with gemcitabine and cisplatin has on advanced bile duct and gallbladder cancers.
|Condition or disease||Intervention/treatment||Phase|
|Extrahepatic Bile Duct Cancer Gallbladder Cancer||Drug: Gemcitabine Drug: Cisplatin Drug: Sorafenib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naïve to Systemic Therapy|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Experimental: Gemcitabine and Cisplatin plus Sorafenib
This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.
Gemcitabine: 800 mg/m^2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.Drug: Cisplatin
20 mg /m^2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.Drug: Sorafenib
400 mg PO once a day continuously.
- Progression-Free Survival [ Time Frame: 6 months ]Progression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first.
- Median PFS [ Time Frame: 6 mos ]Progression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first.
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): NCT00919061
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Ghassan Abou-Alfa, MD||Memorial Sloan Kettering Cancer Center|