Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer

Phase 2

Completed

• Conditions: Biliary Tract Cancer
• Interventions: Drug: Irinotecan and Gemcitabine

• Registration Number: NCT00832689
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-29
• Study First Posted: 2009-01-30
• Primary Completion: 2010-02
• Study Completion: 2010-03
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-25
• Last Update Posted: 2011-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Irinotecan and Gemcitabine	-

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of