Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00832689

Enrollment

Registered

2009-01-30

Start date

2008-06-30

Completion date

2010-03-31

Last updated

2011-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Cancer

Keywords

toxicity

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.

Interventions

DRUGIrinotecan and Gemcitabine

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

17 Years to 75 Years

Healthy volunteers

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026