Radiation Therapy and Docetaxel With Either Fluorouracil or Cisplatin as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

OBJECTIVES:

Primary

• Compare the 6-month progression-free survival rate in patients with unresectable metastatic adenocarcinoma of the pancreas treated with radiotherapy and docetaxel in combination with either fluorouracil or cisplatin as first-line therapy.

Secondary

• Compare the toxicity of these regimens in these patients.
• Compare the objective response rate in patients treated with these regimens.
• Compare overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo radiotherapy to the celiac area once daily 5 days a week for 6 weeks. Patients also receive docetaxel IV weekly and fluorouracil IV daily for 6 weeks.
• Arm II: Patients undergo radiotherapy and receive docetaxel as in arm I. Patients also receive cisplatin IV weekly for 6 weeks.

In both arms, patients experiencing disease progression after completion of chemoradiotherapy may receive additional courses of chemotherapy.

PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 3 years.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

• No other pancreatic tumor type, including either of the following:

• Neuroendocrine tumor
• Ampulla of Vater carcinoma
• Metastatic disease
• Measurable or evaluable disease
• Unresectable disease, defined as either of the following:

• Failed prior attempt of surgical resection by laparotomy
• Surgical resection contraindicated by radiographic criteria (e.g., arterial vascular invasion)
• No cerebral metastases

PATIENT CHARACTERISTICS:

Age

• 18 to 75

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin < 1.5 times upper limit of normal
• No hepatic disturbance

Renal

• Creatinine < 120 mmol/L

Cardiovascular

• No untreated cardiac or coronary insufficiency
• No uncontrolled symptomatic arrhythmia
• No uncontrolled angina

Pulmonary

• No uncontrolled respiratory insufficiency

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix
• No peripheral neuropathy ≥ grade 2
• No ongoing active infection
• No other serious uncontrolled medical disorder that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to the celiac or pancreatic area

Surgery

• See Disease Characteristics