Return to Clinical Trials Search Results

A Phase II-R and a Phase III Trial Evaluating Both Erlotinib (Ph II-R) and Chemoradiation (Ph III) as Adjuvant Treatment for Patients With Resected Head of Pancreas Adenocarcinoma

Primary Objectives (5/12/16) Ph II-R: To determine whether the addition of erlotinib to gemcitabine adjuvant chemotherapy shows a signal for improved survival as compared to gemcitabine alone following R0 or R1 resection of head of pancreas adenocarcinoma (including adenocarcinoma of the head, neck, and uncinate process). Ph III:To determine whether the use of concurrent fluoropyrimidine and radiotherapy following adjuvant gemcitabine based chemotherapy or non-gemcitabine based chemotherapy such as modified FOLFIRINOX further enhances survival for such patients who are without evidence of progressive disease after 5 months of adjuvant chemotherapy. Secondary Objectives (5/12/16) (NOTE: Ph II-R, Erlotinib randomization completed, Arm 2 closed to accrual effective 4/02/14) To evaluate disease-free survival of adjuvant chemotherapy followed by radiotherapy and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after 5 months of adjuvant chemotherapy. To evaluate disease-free survival of standard adjuvant gemcitabine chemotherapy with and without erlotinib for patients with resected head of pancreas adenocarcinoma. To evaluate adverse events with and without erlotinib for patients with resected head of pancreas adenocarcinoma. To evaluate adverse events of adjuvant chemotherapy ± radiation therapy and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after adjuvant chemotherapy. To evaluate preoperative cross-sectional imaging of the primary head of pancreas adenocarcinoma in order to determine the frequency with which objective criteria of resectability are present. To determine if patients reporting low baseline fatigue, as measured by the FACIT-Fatigue, predicts survival and to explore correlations between baseline fatigue, as measured by PROMIS, and survival.

Primary Objectives (5/12/16) Ph II-R: To determine whether the addition of erlotinib to gemcitabine adjuvant chemotherapy shows a signal for improved survival as compared to gemcitabine alone following R0 or R1 resection of head of pancreas adenocarcinoma (including adenocarcinoma of the head, neck, and uncinate process). Ph III:To determine whether the use of concurrent fluoropyrimidine and radiotherapy following adjuvant gemcitabine based chemotherapy or non-gemcitabine based chemotherapy such as modified FOLFIRINOX further enhances survival for such patients who are without evidence of progressive disease after 5 months of adjuvant chemotherapy. Secondary Objectives (5/12/16) (NOTE: Ph II-R, Erlotinib randomization completed, Arm 2 closed to accrual effective 4/02/14) To evaluate disease-free survival of adjuvant chemotherapy followed by radiotherapy and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after 5 months of adjuvant chemotherapy. To evaluate disease-free survival of standard adjuvant gemcitabine chemotherapy with and without erlotinib for patients with resected head of pancreas adenocarcinoma. To evaluate adverse events with and without erlotinib for patients with resected head of pancreas adenocarcinoma. To evaluate adverse events of adjuvant chemotherapy ± radiation therapy and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after adjuvant chemotherapy. To evaluate preoperative cross-sectional imaging of the primary head of pancreas adenocarcinoma in order to determine the frequency with which objective criteria of resectability are present. To determine if patients reporting low baseline fatigue, as measured by the FACIT-Fatigue, predicts survival and to explore correlations between baseline fatigue, as measured by PROMIS, and survival.