Vanderbilt-Ingram Cancer Center

Patients are being asked to take part in this study because you have pancreatic cancer that was removed by surgery. The standard treatment for patients with pancreatic cancer that was removed by surgery is to receive the chemotherapy drug gemcitabine. In this study, patients will get either gemcitabine alone or gemcitabine combined with erlotinib. Erlotinib is a pill that may help treat cancers by blocking a gene that is important in cancer growth. The use of erlotinib to try to prevent the recurrence of pancreatic cancer after surgery is investigational. The purpose of this study is to compare the effects, good and/or bad, of the drug erlotinib in combination with gemcitabine to gemcitabine alone for patients with pancreatic cancer that was removed by surgery to find out which is better. After patients complete 5 months of gemcitabine (with or without erlotinib), all patients will have a CT scan to see if the tumor has not grown back (progressed). Study doctors expect that most patients will not have signs of progression although a few patients may show signs of progression at this point. Patients showing progression will no longer receive treatment on this study. Patients who have not progressed will then be randomized into two groups: * One group will then get one additional month of gemcitabine (with or without erlotinib). * The other group will get one additional month of gemcitabine (with or without erlotinib) and then will get radiation treatments with a fluoropyrimidine for about 5 - weeks. (A fluoropyrimidine is a type of chemotherapy drug that may help radiation be more effective). This study will also determine the effects, good and/or bad, of radiation for patients who remain disease-free after gemcitabine chemotherapy. This study is being conducted by the Radiation Therapy Oncology Group (RTOG). RTOG is a group of researchers at different sites that conduct research for the National Cancer Institute (NCI). Study doctors are members of RTOG or another group participating in the study. About 950 people will take part in this study across all sites. About 12 people will take part at Vanderbilt.

Criteria
 Inclusion Criteria:

 • Histologically confirmed primary adenocarcinoma of the pancreatic head, neck, or uncinate process

 • Intraductal papillary mucinous neoplasm or invasive adenocarcinoma allowed

 • No non-adenocarcinoma, adenosquamous carcinoma, islet cell (neuroendocrine) tumor, cystadenoma, cystadenocarcinoma, carcinoid tumor, duodenal carcinoma, distal bile duct tumor, or ampullary carcinoma

 • Pathologic stage T1-3, N0-1, M0 disease according to American Joint Committee on Cancer (AJCC) 6th edition

 • Has undergone a potentially curative resection (i.e., removal of all gross tumor) involving a classic (Whipple) or a pylorus preserving pancreaticoduodenectomy within the past 21-56 days

 • Operative report must contain a statement from the surgeon explicitly detailing that a total gross excision of the primary tumor was achieved

 • Pathology report must include documentation of margin status, size of the tumor, and status of the 3 major surgical margins (bile duct, pancreatic parenchyma, and retroperitoneal [uncinate])

 • Post-resection serum CA19-9 =< 180 IU/L

 • Tumor tissue block and peripheral blood samples must be submitted to the study's central tumor bank for correlative studies

 • No recurrent pancreatic cancer

 • Zubrod performance status 0-1

 • ANC >= 1,500/mm^3

 • Platelet count >= 100,000/mm^3

 • Hemoglobin >= 8.0 g/dL (transfusion or other intervention allowed)

 • Serum total bilirubin =< 2 times upper limit of normal (ULN)

 • Creatinine =< 2 times ULN

 • SGOT =< 2.5 times ULN

 • Not pregnant or nursing

 • Negative pregnancy test

 • Fertile patients must use effective contraception

 • Suitable to receive study radiotherapy, as documented by a radiation oncologist

 • Active HIV infection allowed provided the CD4 count is >= 499/mm^3 and the viral load is =< 50 copies/mL

 • Total oral caloric intake >= 1,500 calories/day

 • No significant nausea and vomiting

 • None of the following severe active comorbidities that would preclude study therapy:

 • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months

 • Transmural myocardial infarction within the past 3 months

 • Acute bacterial or fungal infection requiring IV antibiotics

 • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy

 • No other invasive malignancies within the past 2 years except for nonmelanomatous skin cancer or carcinoma in situ

 • See Disease Characteristics

 • No prior systemic chemotherapy for pancreatic cancer

 • Prior chemotherapy for a different cancer allowed

 • No prior total pancreatectomy, distal pancreatectomy, or central pancreatectomy

 • No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields

 • Concurrent highly active antiretroviral treatment (HAART) allowed