• Overall survival [ Designated as safety issue: No ]
• Toxicity [ Designated as safety issue: Yes ]

• Overall survival
• Toxicity

• Disease-specific survival [ Designated as safety issue: No ]
• Biochemical failure-free survival [ Designated as safety issue: No ]
• Symptom and treatment-free survival [ Designated as safety issue: No ]
• Qualitiy of life [ Designated as safety issue: No ]

• Disease-specific survival
• Biochemical failure-free survival
• Symptom and treatment-free survival
• Qualitiy of life

RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interferon alfa may interfere with the growth of the tumor cells and slow the growth of cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and interferon alfa with radiation therapy after surgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and interferon alfa together with radiation therapy works in treating patients who have undergone surgery for stage I, stage II, or stage III pancreatic cancer.

OBJECTIVES:

Primary

• Determine the overall survival of patients with previously resected pancreatic adenocarcinoma treated with postoperative cisplatin, interferon alfa, fluorouracil, and concurrent radiotherapy.
• Determine the toxic effects of this regimen in these patients.

Secondary

• Determine the disease-specific, biochemical failure-free, and symptom/treatment-free survival of patients treated with this regimen.
• Determine the quality of life of patients treated with this regimen.

OUTLINE:

• Chemoradiotherapy: Patients receive fluorouracil IV continuously and interferon alfa subcutaneously 3 times per week (total of 17 doses) on days 1-19 and 29-45 and cisplatin IV over 6 hours on days 1, 8, 15, 29, 36 and 43. Patients also undergo concurrent radiotherapy once daily, 5 days a week in weeks 1-3 and 5-7 (28 fractions).
• Post-chemoradiotherapy fluorouracil: Patients receive fluorouracil IV continuously on days 71-108 and 127-168.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

• Biological: recombinant interferon alfa
• Drug: cisplatin
• Drug: fluorouracil
• Procedure: adjuvant therapy
• Radiation: radiation therapy

DISEASE CHARACTERISTICS:

• Histologically confirmed pancreatic adenocarcinoma of the pancreatic head or uncinate process

  • Stage I, II, or III

• Completely resected disease (R0 or R1)

  • Postoperative CA 19-9 less than 100
  • Study treatment must begin within 12 weeks of surgery
• Postoperative CT scan without evidence of radiographically definable residual primary/metastatic disease or clinically significant postsurgical changes

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC greater than 3,000/mm^3
• Absolute neutrophil count greater than 1,500/mm^3
• Platelet count greater than 75,000/mm^3
• Hemoglobin greater than 9.0 g/dL

Hepatic

• Not specified

Renal

• Creatinine less than 1.5 mg/dL
• Creatinine clearance at least 60 mL/min
• Bilateral renal function by excretory urogram (IVP) or abdominal CT scan OR at least 2/3 of 1 functioning kidney must be able to be shielded from the radiotherapy beam

Cardiovascular

• No significant cardiovascular disease
• No unstable angina
• No congestive heart failure

Pulmonary

• No severe pulmonary disease

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• Prior history of non-pancreatic malignancy allowed at the discretion of the study chair provided patient is free of the primary cancer
• No concurrent acute infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics