Clinical Trial: Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naive to Systemic Therapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naïve to Systemic Therapy

Brief Summary:

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.


Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome:

  • 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.


Original Primary Outcome: To determine the 6 month progression-free survival rate for patients with advanced biliary tract carcinomas treated with gemcitabine and cisplatin plus sorafenib. [ Time Frame: the six months CTscan can occur anytime within two weeks before or two weeks after the 6 months mark ]

Current Secondary Outcome:

Original Secondary Outcome:

  • To determine the toxicity profile, radiologic response rate, and associated time to progression and overall survival. [ Time Frame: toxicity assessment week 1 & 2 then every cycle, Re-staging imaging studies will be obtained every 3 cycles. ]
  • To correlate, progression-free survival, response, time to progression and overall survival with pre-treatment tumor-cell pERK expression. [ Time Frame: 2 years ]


Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: June 11, 2009
Date Started: August 2009
Date Completion:
Last Updated: January 4, 2016
Last Verified: January 2016