Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery

OBJECTIVES:

Primary

• Compare the 3-month progression rate in patients with unresectable, nonmetastatic cancer of the biliary tract treated with fluorouracil, cisplatin, and radiotherapy vs gemcitabine hydrochloride and oxaliplatin. (phase II)
• Compare the overall survival of patients treated with these regimens. (phase III)

Secondary

• Compare toxicities of these regimens in these patients. (phase II)
• Compare the quality of life at initial drainage (phase II) and overall (phase III) of patients treated with these regimens.
• Compare the biliary complication rate in patients treated with these regimens.
• Compare the duration of hospitalization of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease location (gallbladder vs intrahepatic biliary duct vs extrahepatic biliary duct). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo radiotherapy once daily, 5 days a week on days 1-33. Patients also receive fluorouracil IV continuously over 5 days once a week in weeks 1-5 and cisplatin IV over 15 minutes on days 1-4 and 29-32 (or days 1 or 2 and 29 or 30) in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 3 months thereafter.

After completion of study therapy, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 170 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of cancer of the biliary tract by 1 of the following methods:

• Histologic confirmation
• Stenosis of the biliary tract by MRI, CT scan, or ECHO
• Unresectable disease
• Amenable to radiotherapy
• No visceral metastases by imaging

• Hepatic adenopathies that can be included in a radiation field allowed
• No known ampulla of Vater or pancreatic cancer involving the biliary tract

PATIENT CHARACTERISTICS:

• WHO performance status 0-2
• Creatinine < 1.5 mg/dL
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 75,000/mm^3
• Prothrombin time > 70%
• Bilirubin ≤ 2.9 mg/dL (after hepatic draining, if needed)
• No unstable angina
• No symptomatic cardiac insufficiency
• No other comorbidity that would preclude study therapy
• No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
• No prior hydatid cyst or alveolar echinococciasis
• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

• No recent biliary surgery
• No hepatic intra-arterial chemotherapy
• No prior anticancer therapy