Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer

Yonsei University

Status and phase: Completed; Phase 2

Conditions: Biliary Tract Cancer

Treatments: Drug: Irinotecan and Gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00832689

4-2007-0191

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 17 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

39 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Irinotecan and Gemcitabine