Chemotherapy, Interferon Alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For 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 intravenous (IV) continuously and interferon alfa subcutaneously (SQ) 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.

Inclusion criteria

• Biopsy proven completely resected (R0 or R1) pancreatic adenocarcinoma of the pancreatic head or uncinate process [American Joint Committee on Cancer (AJCC) Stage I-III]. Surgery (pancreaticoduodenectomy) may be performed at M. D. Anderson Cancer Center or prior to referral to M. D. Anderson Cancer Center. Protocol treatment must begin within 12 weeks of surgery.
• Postoperative (pre-treatment) computed tomography (CT) scan without evidence of radiographically defineable residual primary/metastatic disease or clinically significant post-surgical changes.
• Staging studies completed within three weeks +/- 3 days of protocol registration.
• Hemoglobin (Hb) >9.0 g/%, White Blood Count (WBC) >3,000 cells/mm3 (Absolute neutrophil count (ANC)>1,500 cells/mm3), platelets >75,000 cells/mm3.
• Postoperative serum calcium (CA) 19-9 < 100.
• Performance status: Zubrod 0 or 1.
• Creatinine £1.5 mg/dL and calculated or measured creatinine clearance (CrCl) of 60 ml/min or greater by the following formula: Creatinine clearance rate (CrCl) = (140 - age) * Weight (kg) * 0.85 (female) OR * 1.00 (male) 72 * serum creatinine
• Patients should have bilateral renal function, as determined on excretory urogram (IVP) or abdominal CT, or ³ 2/3 of one functioning kidney must be able to be shielded from the radiation beam.
• No acute infections at the time of therapy initiation.
• Women of childbearing potential must agree to practice adequate contraception and to refrain from breast feeding, as specified in the informed consent.
• Patients must sign a study-specific consent form, which is attached to this protocol.
• Patients with a prior history of non-pancreatic malignancy who are free of disease from their primary cancer may be eligible at the discretion of the study chair.

Exclusion criteria

• Residual (clinical or CT definable) metastatic or incompletely resected local disease.
• Patients with positive peritoneal cytology (for adenocarcinoma) detected at laparotomy for pancreaticoduodenectomy or as part of prior laparoscopic assessment of peritoneal cytology.
• Patients with a history of hypersensitivity to interferon alfa-2b.
• Patients with significant cardiovascular disease, such as unstable angina or congestive heart failure.
• Pregnancy or breastfeeding.
• Patients with severe pulmonary disease.
• Children under the age of 18 are excluded (as the disease is rare and toxicity profile of this regimen untested in pediatric patients).
• Presence or history of severe depression.