• Overall survival at 18 months [ Designated as safety issue: No ]
  

• Toxicity [ Designated as safety issue: Yes ]
  
• Disease-free survival [ Designated as safety issue: No ]
  
• Local-regional disease control [ Designated as safety issue: No ]
  
• Distant disease control [ Designated as safety issue: No ]
  

OBJECTIVES:

• Determine the disease-free and overall survival of patients with resected pancreatic adenocarcinoma treated with adjuvant chemoradiotherapy comprising fluorouracil, cisplatin, and interferon alfa.
• Determine the rate and severity of acute and late toxic effects in patients treated with this regimen.
• Determine the local-regional disease control and distant disease control in patients treated with this regimen.

OUTLINE: This is a multicenter study.

• Chemoradiotherapy (CRT): Patients receive fluorouracil IV continuously on days 1-38; cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36; and interferon alfa subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, and 38. Patients also undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38.
• Post-CRT chemotherapy: Beginning 4-6 weeks after the completion of CRT, patients receive fluorouracil IV continuously on days 1-42. Treatment repeats every 56 days for a total of two courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 93 patients will be accrued for this study within 2 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the head of the pancreas

  • Stage I, II, or III (T1-4, N0-1, M0)
  • No recurrent pancreatic cancer

• Must have undergone a potentially curative gross total resection by pancreaticoduodenectomy within the past 56 days

  • Must have R0 (no residual tumor) or R1 (microscopic residual tumor) grade disease post-resection

• No pancreaticoduodenectomy histopathology indicating any of the following types:

  • Adenosquamous carcinoma
  • Ampullary carcinoma
  • Carcinoid tumor
  • Cystadenocarcinoma
  • Cystadenoma
  • Distal common bile duct carcinoma
  • Duodenal carcinoma
  • Islet cell carcinoma
• No metastatic disease by CT scan of the chest and CT scan with intravenous contrast (or MRI) of abdomen/pelvis

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1 OR
• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm^3
• Absolute neutrophil count greater than 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin greater than 9.5 g/dL

Hepatic

• Bilirubin no greater than 3 mg/dL
• AST and ALT no greater than 2 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Stable or increasing weight within 14 days before start of study treatment (otherwise supplemental nutrition, such as feeding jejunostomy, percutaneous endoscopic gastrostomy, or total parenteral nutrition, must be initiated)
• No evidence of recurrence of any prior malignancy
• No other malignancies within the past 5 years except successfully treated carcinoma in situ of the cervix, lobular carcinoma in situ of the breast, or nonmelanoma skin cancer
• No preexisting psychiatric condition (especially depression) or a history of severe psychiatric disorders

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic or immunologic therapies
• No concurrent biological response modifiers for pancreatic cancer
• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
• No concurrent oprelvekin

Chemotherapy

• No prior systemic chemotherapy for pancreatic cancer

Endocrine therapy

• No concurrent dexamethasone

Radiotherapy

• No prior radiotherapy for pancreatic cancer
• No prior external beam photon (x-ray) therapy to the chest, abdomen, or pelvis
• No concurrent intensity modulated radiotherapy

Surgery

• See Disease Characteristics

Other

• Underwent potentially curative therapy for any prior malignancies
• No prior chronic immunosuppressive therapy (e.g., prednisone or methotrexate) for collagen vascular disease or other chronic immunologic abnormality
• No concurrent theophylline
• No concurrent aminoglycoside antibiotics
• No concurrent halogenated antiviral agents (e.g., sorivudine)
• No other concurrent investigational drugs for pancreatic cancer
• No other concurrent systemic or loco-regional therapy for pancreatic cancer