Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The study hypothesis is that chemotherapy of irinotecan and gemcitabine will improve local control of cancer and prolong survival in patients with inoperable biliary tract cancer.

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

Details

• Lead Sponsor: Yonsei University
• Treatments: Gemcitabine; Irinotecan

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed inoperable biliary tract cancer

• Age: 18 ~75 years old

• Performance status: ECOG 0-2

• Hematopoietic:

• Granulocyte count at least 1,500/mm3

• Platelet count at least 100,000/mm3

• Hepatic:

• Bilirubin No greater than 2 fold the upper normal limit

• AST/ALT : No greater than 3 fold the upper normal limit

• Renal:

• Creatinine - no greater than 1.5 mg/dL

• Not pregnant

• No other serious medical or psychiatric illness that would preclude giving informed consent or limit

• No prior chemotherapy within 6 months

• No other concurrent anticancer radiotherapy within 6 months