Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Cisplatin; Gemcitabine

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