Chemotherapy, Interferon Alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer
Chemotherapy, Interferon Alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer
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 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:

 1. 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.

 2. Postoperative (pre-treatment) computed tomography (CT) scan without evidence of
 radiographically defineable residual primary/metastatic disease or clinically
 significant post-surgical changes.

 3. Staging studies completed within three weeks +/- 3 days of protocol registration.

 4. 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.

 5. Postoperative serum calcium (CA) 19-9 < 100.

 6. Performance status: Zubrod 0 or 1.

 7. 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

 8. 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.

 9. No acute infections at the time of therapy initiation.

 10. Women of childbearing potential must agree to practice adequate contraception and to
 refrain from breast feeding, as specified in the informed consent.

 11. Patients must sign a study-specific consent form, which is attached to this protocol.

 12. 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:

 1. Residual (clinical or CT definable) metastatic or incompletely resected local disease.

 2. Patients with positive peritoneal cytology (for adenocarcinoma) detected at laparotomy
 for pancreaticoduodenectomy or as part of prior laparoscopic assessment of peritoneal
 cytology.

 3. Patients with a history of hypersensitivity to interferon alfa-2b.

 4. Patients with significant cardiovascular disease, such as unstable angina or
 congestive heart failure.

 5. Pregnancy or breastfeeding.

 6. Patients with severe pulmonary disease.

 7. Children under the age of 18 are excluded (as the disease is rare and toxicity profile
 of this regimen untested in pediatric patients).

 8. Presence or history of severe depression.