Brief Title
Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer
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
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Percentage of Patients Alive at 1 Year (1-Year Survival Rate)
Secondary Outcome
Tumor Response
Condition
Biliary Tract Cancer
Intervention
gemcitabine
Study Arms / Comparison Groups
Gemcitabine + Cisplatin
Description: Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
84
Start Date
September 2006
Completion Date
October 2008
Primary Completion Date
October 2008
Eligibility Criteria
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
Gender
All
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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), ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT00380588
Organization ID
10298
Secondary IDs
B9E-JE-BT22
Study Sponsor
Eli Lilly and Company
Study Sponsor
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), Study Director, Eli Lilly and Company
Verification Date
November 2009