Adjuvant Chemoradiotherapy and Interferon Alfa in Treating Patients With Resected 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.