Status:
COMPLETED
Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- radiological or clinical evidence of pulmonary fibrosis or interstitial pneumonia
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00380588
Start Date
September 1 2006
End Date
October 1 2008
Last Update
November 20 2009
Active Locations (7)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aichi, Japan, 466-8560
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chiba, Japan, 277-8577
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fukuoka, Japan, 811-1395
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hokkaido, Japan, 060-8648