Overview

Gemcitabine/Cisplatin/S-1(GCS) Combination Therapy for Patients With Advanced Biliary Tract Cancer

Status:
Completed

Trial end date:
2013-08-01

Target enrollment:
0

Participant gender:
All

Summary

The objective of this study is to evaluate the safety of GCS therapy for phase I and efficacy of GCS therapy for phase II.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Kansai Hepatobiliary Oncology Group

Treatments:

Cisplatin
Gemcitabine

Criteria

Inclusion Criteria:

- 1. Patients with cytologically or histologically proved biliary tract cancer 2. age
>=20 years 3. PS 0-2 4. No prior history of chemotherapy or radiotherapy. Patients who
have undergone adjuvant chemotherapy are eligible if at least 6 months have passed
since the last administration.

5. Adequate bone marrow function (neutrophil count >=1,500/mm3, and platelet count
>=100,000/mm3), liver function (total bilirubin >=3 mg/dL and AST/ALT >=150 IU/L), and
renal function (creatinine clearance >=60 mL/min) 6.No other serious comorbid disease
7.Adequate oral intake 8.Provided written informed consent

Exclusion Criteria:

- 1. Patients with interstitial pneumonia or pulmonary fibrosis 2. Patients with
uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of
myocardial infarction within 3 months 3. Patients with severe active infection 4.
Patients who are pregnant or lactating, or have an intention to get pregnant 5.
Patients with a history of severe drug allergy 6. Patients with other serious comorbid
disease 7. Patients with mental disease 8. Patients who are judged inappropriate for
the entry into the study by the principle doctor 9. Patients with watery diarrhea