Clinical Trial: Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized Study of Gemcitabine/Cisplatin Versus Single-Agent Gemcitabine in Patients With Biliary Tract Cancer
Brief Summary: To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer
Detailed Summary:
Sponsor: Eli Lilly and Company
Current Primary Outcome: Percentage of Patients Alive at 1 Year (1-Year Survival Rate) [ Time Frame: 1 year ]
Original Primary Outcome: To verify that gemcitabine/cisplatin combination therapy shows higher 1-year survival rate than gemcitabine monotherapy in chemotherapy-naïve patients with locally advanced or metastatic biliary tract cancer
Current Secondary Outcome:
- Tumor Response [ Time Frame: baseline to measured progressive disease (up to 2 years) ]
- Progression Free Survival [ Time Frame: baseline to measured progressive disease (up to 2 years) ]
Original Secondary Outcome: Characterize the nature of the toxicities experienced in each arm; Objective response rate; Progression-free survival; Disease control rate (CR, PR, SD [ * 12 weeks ])
Information By: Eli Lilly and Company
Dates:
Date Received: September 22, 2006
Date Started: September 2006
Date Completion:
Last Updated: November 18, 2009
Last Verified: November 2009
