A Phase II Study of Gemcitabine With Oxaliplatin as First Line Chemotherapy in Advanced Biliary Tract Cancer

Treatment scheme

:Gemcitabine 1000 mg/m2/d IV D1 as a 10mg/m2/min Oxaliplatin 85 mg/m2/d IV D2 as a 2 hours infusion

Each cycle is repeated every 2 weeks.

Repeated cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity. Subjects will be treated for at least 4 cycles unless there is documented disease progression, unacceptable adverse events or withdrawal of consent.

Inclusion criteria

• Patients with histologically or cytologically confirmed biliary tract adenocarcinoma
• 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 margin.

• Presence of metastatic lesion

• Unresectable recurrent tumor after curative resection

• anatomically resectable but inoperable associated with medical condition
• Biliary obstruction controlled
• Minimum life expectancy of 12 weeks.
• At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) or evaluable lesion present by imaging study
• Age over 18 years
• ECOG performance status of * 2.
• 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
• Consent form signed and dated prior to study specific procedures.
• Subject able to comply with the scheduled follow-up and with the management of toxicities.

Exclusion criteria

• Decompensated Cirrhosis or stage C (Index > 10) according to the Child-Pugh Classification
• Prior systemic chemotherapy
• Subject with reproductive potential (M/F) not using adequate contraceptive measures.
• Pregnancy and breast-feeding.
• Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).
• Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
• Symptomatic or uncontrolled brain metastasis
• Other concomitant anticancer agent, including Tamoxifen and Interferon.
• Subjects who cannot be regularly followed up for psychological, social, familial or geographic reasons.
• Participation in another clinical study or within 30 days before inclusion.
• History of severe hypersensitivity reactions to gemcitabine or oxaliplatin