A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma

CTO - 6100
Cancer - Pancreatic
Principal Investigator: Eleanor M Walker, MD

This randomized Phase III trial is studying gemcitabine hydrochloride and erlotinib hydrochloride to see how well they work compared with gemcitabine hydrochloride alone followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and/or radiation therapy in treating pancreatic cancer.

  1. Adults at least 18 years of age
  2. Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection (i.e. removal of all gross tumor) involving a classic (Whipple) or a pylorus preserving pancreaticoduodenectomy
Open
Tiffany Pearce
(313) 916-1784