A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Pancreatic Cancer

Protocol
10-083
Full Title
A Phase IIR and A Phase III Trial Evaluating Both Erlotinib (Ph IIR) and Chemoradiation (Ph III) as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma (RTOG 0848)
Phase
III
Purpose

Patients with pancreatic cancer that has been surgically removed usually receive chemotherapy plus radiation therapy. In this study, researchers want to see if giving the chemotherapy drug gemcitabine without radiation is equivalent to chemoradiation. They also want to observe the effects of adding the drug erlotinib to gemcitabine therapy after surgery.

Patients will receive gemcitabine either alone or with erlotinib. Patients will be randomly assigned to one treatment group or the other. Erlotinib is a pill that may help treat cancers by blocking a gene that is important in cancer growth. It is approved for treating advanced pancreatic cancer, but its use to prevent pancreatic cancer from returning after surgery is considered investigational.

After five months, if there is no evidence of disease recurrence, patients will be randomly assigned to receive an additional cycle of chemotherapy with or without radiation therapy. Patients who receive radiation therapy will also receive a drug called fluoropyrimidine, which enhances the effect of the radiation.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have pancreatic adenocarcinoma that has been surgically removed.
  • Patients may not have had prior chemotherapy or radiation therapy for pancreatic cancer.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Karyn Goodman at 212-639-3983.

Disease(s)
Hepatobiliary: Pancreatic Cancer
Upper Gastrointestinal: Pancreatic Cancer
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