A Phase II Study of Gemcitabine in Combination With Oxaliplatin as First Line Chemotherapy in Patients With Inoperable Biliary Tract Adenocarcinoma
1. Patients with histologically or cytologically confirmed biliary tract adenocarcinoma
2. Inoperable disease as defined by:
- Localized disease in a portion of the liver that does not allow the
possibility of complete surgical removal of the tumor with a clear resection
- Presence of metastatic lesion
- Unresectable recurrent tumor after curative resection
- anatomically resectable but inoperable associated with medical
3. Biliary obstruction controlled
4. Minimum life expectancy of 12 weeks.
5. At least one measurable lesion according to the Response Evaluation Criteria in Solid
Tumors (RECIST) or evaluable lesion present by imaging study
6. Age over 18 years
7. ECOG performance status of * 2.
8. Adequate organ function as evidenced by the following; Absolute neutrophil count >
1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤3xUNL; AST and/or ALT < 5x
UNL; Creatinine< 1.5mg/dl or creatinine clearance >50 ml/mins
9. Consent form signed and dated prior to study specific procedures.
10. Subject able to comply with the scheduled follow-up and with the management of
1. Decompensated Cirrhosis or stage C (Index > 10) according to the Child-Pugh
2. Prior systemic chemotherapy
3. Subject with reproductive potential (M/F) not using adequate contraceptive measures.
4. Pregnancy and breast-feeding.
5. Other serious illness or medical condition, notably heart or lung failure, active
uncontrolled infection (infection requiring antibiotics).
6. Past or concurrent history of other neoplasm, except curatively treated basal cell
skin cancer or adequately treated in-situ carcinoma of the cervix.
7. Symptomatic or uncontrolled brain metastasis
8. Other concomitant anticancer agent, including Tamoxifen and Interferon.
9. Subjects who cannot be regularly followed up for psychological, social, familial or
10. Participation in another clinical study or within 30 days before inclusion.
11. History of severe hypersensitivity reactions to gemcitabine or oxaliplatin