A Randomized Study of Gemcitabine/Cisplatin Versus Single-Agent Gemcitabine in Patients With Biliary Tract Cancer
Phase 2
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Biliary Tract Cancer
Both
Biliary Tract Cancer
Trial Information
A Randomized Study of Gemcitabine/Cisplatin Versus Single-Agent Gemcitabine in Patients With Biliary Tract Cancer
Inclusion Criteria:
- Histological or cytological diagnosis of biliary tract cancer
- Measurable disease must be at least one lesion
- Chemotherapy-naïve
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Estimated life expectancy no less than 3 months
Exclusion Criteria:
- radiological or clinical evidence of pulmonary fibrosis or interstitial pneumonia
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of Patients Alive at 1 Year (1-Year Survival Rate)
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
10298
NCT ID:
NCT00380588
Start Date:
September 2006
Completion Date:
October 2008
Related Keywords:
- Biliary Tract Cancer
- Biliary Tract Neoplasms
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