Phase II Trial of Erlotinib in Advanced Pancreatic Cancer
This is an open-label, multi-center phase II study of erlotinib in patients with metastatic or locally advanced, unresectable pancreatic cancer who have received up to one line of gemcitabine based chemotherapy.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Erlotinib in Advanced Pancreatic Cancer|
- Primary objective: To determine the efficacy of erlotinib, as measured by the rate of disease control (objective response plus prolonged stable disease), in patients with unresectable, locally advanced or metastatic pancreatic adenocarcinoma. [ Time Frame: Clinically assessed every cycle (month) and radiologically assessed every 2 cycles (2 months) with CT scan ] [ Designated as safety issue: Yes ]
- To determine the toxicity of erlotinib in this setting. [ Time Frame: assessed every cycle (month) ] [ Designated as safety issue: Yes ]
- To determine the feasibility, safety, and efficacy of erlotinib dose escalation in patients who do not develop a rash by cycle 1, day 15. [ Time Frame: assessed cycle 1, day 28, then every cycle (month) ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2006|
|Study Completion Date:||June 2013|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Erlotinib starting at 150 mg PO (by mouth) daily. Dose may increase or decrease by the study doctor as per protocol (study plan).
Erlotinib in addition to gemcitabine significantly improves overall survival compared to gemcitabine alone in advanced pancreatic cancer (median overall survival 6.24 vs 5.91 months respectively). However, combined therapy has not become standard of care due to the modest absolute benefit. In NSCLC, the optimal efficacy of erlotinib is not in combination with first-line cytotoxic chemotherapy for advanced disease, but as a single agent after cytoxic chemotherapy. Preclinical and clinical data suggest that erlotinib will have activity as a single agent in advanced pancreatic cancer. The presence of an erlotinib-induced rash is associated with improved survival in phase II and III trials of diverse tumor types (reviewed by Perez-Soler et al.), and is associated with higher steady state concentrations of erlotinib.
This phase II trial aims to determine the safety and efficacy of erlotinib in patients with advanced pancreatic cancer who have previously been treated with up to one prior line of gemcitabine based chemotherapy for advanced disease. In addition, we will evaluate the feasibility and activity of dose escalation of erlotinib in patients who do not develop a rash. Clinical outcome will be correlated to EGFR status based on immunohistochemistry and gene amplification status as well as Kras mutations from archival tumor tissue.
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|British Columbia Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Winnipeg, Manitoba, Canada, R2H 2A6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Malcolm Moore, MD||Drug Development Program, Princess Margaret Hospital|