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

PURPOSE: Phase II trial to study the effectiveness of adjuvant chemoradiotherapy and interferon alfa in treating patients who have resected stage I, stage II, or stage III pancreatic cancer.

Condition	Treatment or Intervention	Phase
stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas	Drug: cisplatin  Drug: fluorouracil  Drug: interferon alfa  Procedure: adjuvant therapy  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: cytokine therapy  Procedure: interferon therapy  Procedure: radiation therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Florida
      University of Florida Shands Cancer Center, Gainesville,  Florida,  32610-100277,  United States; Recruiting
Georgia
      Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah,  Georgia,  31403-3089,  United States; Recruiting
Illinois
      Rush University Medical Center, Chicago,  Illinois,  60612-3833,  United States; Recruiting
Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States; Recruiting
Massachusetts
      Brigham and Women's Hospital, Boston,  Massachusetts,  02115,  United States; Recruiting
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02115,  United States; Recruiting
Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States; Recruiting
New York
      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States; Recruiting
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States; Recruiting
North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
Texas
      Presbyterian Hospital of Dallas, Dallas,  Texas,  75231,  United States; Recruiting
Washington
      Cancer Institute at Virginia Mason Medical Center, Seattle,  Washington,  98111,  United States; Recruiting
Wisconsin
      Froedtert Memorial Lutheran Hospital, Milwaukee,  Wisconsin,  53226,  United States; Recruiting
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-7375,  United States; Recruiting

Study chairs or principal investigators

Vincent J. Picozzi, MD,  Study Chair,  Cancer Institute at Virginia Mason Medical Center   

Study ID Numbers:  CDR0000298776; ACOSOG-Z05031; NCT00059826
Record last reviewed:  September 2004
Last Updated:  April 4, 2005
Record first received:  May 6, 2003
ClinicalTrials.gov Identifier:  NCT00059826
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08