Adjuvant Chemoradiotherapy and Interferon Alfa in Treating Patients With Resected Pancreatic Cancer
Adjuvant Chemoradiotherapy and Interferon Alfa in Treating Patients With Resected Pancreatic Cancer
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.
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.
Inclusion Criteria:

 1. Patient must be > 18 years of age.

 2. Patient must have a documented ECOG/Zubrod performance status of 0 or 1, within 7 days
 prior to registration.

 3. Patient must have pathological stage T1-3, N0-1, M0 adenocarcinoma of the head of the
 pancreas according to the American Joint Committee on Cancer (AJCC) staging system.

 -  NOTE: The pathology report must be submitted to ACOSOG on the Pathology Report
 Shuttle CRF.

 4. Patient must have undergone a potentially curative gross total resection by
 pancreaticoduodenectomy (includes R0 [no residual tumor] or R1 [microscopic residual
 tumor]) within 56 days prior to beginning treatment. NOTE: The operative report must
 be submitted to ACOSOG on the Operative Report Shuttle CRF.

 5. Patient must have stable or increasing weight in the 14 days prior to the start of
 treatment, otherwise supplemental nutrition (e.g. feeding jejunostomy, PEG, TPN) must
 be initiated prior to the start of treatment.6. Patient must have adequate bone
 marrow, hepatic and renal function, within 7 days prior to registration:

 -  WBC > 3,000 mm^3

 -  ANC > 1,500 mm^3

 -  hemoglobin > 9.5 mg/dl

 -  platelet count > 100,000 mm^3

 -  total bilirubin < 3 mg/dl

 -  AST (SGOT) < 2.0 times institutional upper limit of normal (ULN)

 -  ALT (SGPT) < 2.0 times institutional ULN

 -  alkaline phosphatase < 2.0 times institutional ULN

 -  serum creatinine < 1.5 times institutional ULN

 7. Patient must have a baseline diagnostic CT scan of the chest and CT scan with IV
 contrast (or MRI) of abdomen/pelvis, within 30 days prior to registration, to exclude
 metastatic disease.

 8. If female of childbearing potential, patient must have a negative urine or serum
 pregnancy test, within 7 days prior to registration. NOTE: Postmenopausal women must have
 been amenorrheic for at least 12 consecutive months to be considered not of childbearing
 potential.

 9. Patient (male or female) of reproductive potential must agree to use medically
 acceptable contraception during the study. NOTE: Medically acceptable contraceptives
 include: (1) surgical sterilization, (2) approved hormonal contraceptives (such as birth
 control pills, Depo-Provera, or Lupron Depot), (3) barrier methods (such as a condom or
 diaphragm) used with a spermicide, or (4) an intrauterine device (IUD).

 10. Patient, or the patient's legally acceptable representative, must sign and date an
 informed consent PRIOR to registration and the performance of any study related procedures.

 11. Patient, or the patient's legally acceptable representative, must provide written
 authorization to allow the use and disclosure of their protected health information.

 - NOTE: This may be obtained in either the study-specific informed consent or in a separate
 authorization form and must be obtained from the patient prior to study registration.

 12. If patient is a cancer survivor, all of the following criteria must be met and
 documented in the patient's medical record:

 1. Patient has undergone potentially curative therapy for all prior malignancies.

 2. No evidence of prior malignancies for at least 5 years (except for successfully
 treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, or
 nonmelanoma skin cancer).

 3. No evidence of recurrence of any prior malignancy.

 Exclusion Criteria:

 1. Patient has pancreaticoduodenectomy histopathology of adenosquamous carcinoma,
 ampullary carcinoma, carcinoid tumor, cystadenocarcinoma, cystadenoma, distal common
 bile duct carcinoma, duodenal carcinoma, or islet cell carcinoma.

 2. Patient is pregnant or lactating.

 3. Patient has recurrent pancreatic cancer.

 4. Patient has received prior systemic chemotherapy or radiotherapy for pancreatic
 cancer.

 5. Patient has received external beam photon (x-ray) therapy to the chest, abdomen or
 pelvis.

 6. Patient has received any biologic/ immunologic therapies.

 7. Patient has received chronic immunotherapy (e.g. prednisone or methotrexate) for
 collagen vascular disease or other chronic immunologic abnormality.

 8. Patient has a preexisting psychiatric condition, especially depression, or a history
 of severe psychiatric disorders.