Pemetrexed, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed carcinoma arising from the pancreas Stage II or III disease, meeting 1 of the following criteria: Nonresectable disease Potentially resectable disease Resectable disease Stage IV disease with symptomatic back pain requiring palliation allowed at the discretion of the principal investigator Measurable, evaluable, or nonmeasurable disease No neuroendocrine tumor of the pancreas No documented brain metastasis No clinically significant pleural or peritoneal effusions that cannot be drained PATIENT CHARACTERISTICS: ECOG performance status 0-1 Life expectancy ≥ 12 weeks Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 9 g/dL Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver has tumor involvement) AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement) Creatinine clearance ≥ 45 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment No active infection No serious systemic disorders that would preclude study treatment No significant cardiovascular disease in the form of abnormal electrocardiogram coupled with clinical features of recent or recurrent cardiac disease (including myocardial infarction, angina, or hypertension) PRIOR CONCURRENT THERAPY: More than 4 weeks since prior investigational agents No prior chemotherapy for pancreatic cancer Must be able to discontinue aspirin, dexamethasone, and other nonsteroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after pemetrexed disodium dose (5 days before for long-acting agents such as piroxicam) Must be able and willing to take folic acid and cyanocobalamin (vitamin B12) supplementation
Sites / Locations
- Wake Forest University Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Pemetrexed in combination with concomitant radiotherapy
Patients will receive Pemetrexed plus Radiotherapy.