Chemotherapy, Interferon Alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Recombinant Interferon Alfa; Cisplatin; Fluorouracil; Radiation Therapy
Intervention description: 3 million units subcutaneously every other day (Monday, Wednesday and Friday) during Days 1-19 and 29-45, for 6 1/2 weeks totaling 17 doses.; 30 mg/m^2 IV over 60 minutes on days 1, 8, 15, 29, 36, 43 - weekly for total 6 doses, during 5 1/2 weeks radiation therapy.; 175 mg/m^2/day continuous infusion over 6 1/2 weeks for total 3 courses: Days 1-19 and 29-45, Days 71-108 and Days 127-168.; External beam radiation on days 1-19 and days 29-45, 9 day treatment break on day 20.
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Cisplatin; Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer; adenocarcinoma of the pancreas

Summary:

      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.
    

Eligibility criteria:

        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.