A Pancreatic cancer study
This study is for patients with pancreatic cancer that was removed by surgery. The standard chemotherapy for pancreatic cancer is the chemotherapy drug, gemcitabine. Gemcitabine is considered the most active chemotherapy drug for pancreatic cancer. In this study patients will receive either gemcitabine alone or gemcitabine combined with erlotinib (trade name Tarceva). Erlotinb is a pill that may help treat cancers by blocking a gene that is important in cancer growth If after 5 months of chemotherapy your cancer has not grown back you will be randomized again to either the same chemotherapy received in the first 5 months or receive radiation and fluoropyrimidine ( a type of chemotherapy drug that may help radiation be more effective.
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. Patients will be randomized into two groups either gemcitabine alone or gemcitabine plus tarceva.When patients have completed 5 months of chemotherapy they will be randomized again into two groups. One group will receive the same chemotherapy they received in the first 5 months while the other group will get an additional cycle of the same chemotherapy along with radiation therapy and fluoropyrimidine. Radiation will be given once a day, Monday through Friday for 51/2 weeks ( 28 radiation treatments)
Patients must have histologic proof of primary head of pancreas cancer. Patients must have had surgery 21-56 days before registration.
Alexander Hindenburg, MD