Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer

Biliary Tract Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832689
• Other study ID #: 4-2007-0191
• Status: Completed
• Phase: Phase 2
• First received: January 29, 2009
• Last updated: March 25, 2011
• Start date: June 2008
• Est. completion date: March 2010

Study information

• Verified date: March 2011
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 75 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• Irinotecan and Gemcitabine

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of,