Salvage mFOLFOX in BTC After Failure of Gemcitabine

Chung-Ang University

Status and phase: Completed; Phase 2

Conditions: Unresectable Biliary Tract Cancer

Treatments: Drug: 5-fluorouracil, leucovorin, oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01127555

CAUHHO 2010-2

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of mFOLFOX (5-fluorouracil, leucovorin, oxaliplatin)as salvage therapy in patients with unresectable biliary tract cancer who had failed gemcitabine.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age : older than 18
2. Histologically confirmed adenocarcinoma of the biliary tract
3. Metastatic or unresectable biliary cancer
4. Prior exposure to gemcitabine chemotherapy for biliary cancer
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
6. A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in spiral Computed Tomography (CT) or multidetector CT
7. Adequate bone marrow, liver, renal function

Exclusion criteria

1. Pregnancy and breast-feeding.
2. Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).
3. Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
4. Symptomatic or uncontrolled brain metastasis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)