Phase II Study of Gemcitabine and Intermittent Erlotinib in Advanced Pancreatic Cancer (OSI 4132s)
OUTLINE: This is a multicenter study.
Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15 and oral erlotinib
hydrochloride on days 2-5, 9-12, and 16-26. Treatment repeats every 28 days for up to 1 year
in the absence of disease progression or unacceptable toxicity.
Archived tumor tissue samples are analyzed for the expression of EGFR, HER3, HER2,
downstream signaling molecules, and other molecular markers by immunohistochemistry and
RT-PCR. The presence of aberrant gene copy numbers (amplification and polysomy) for EGFR,
HER3, and HER2 are determined by FISH. Blood samples are collected at baseline and
periodically during study for polymorphism analysis and correlative molecular analysis of
surrogate endpoint biomarkers.
After completion of study therapy, patients are followed every 3 months.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (partial response or complete response) and duration of response
Every 8 weeks
Primo N. Lara, MD
University of California, Davis
United States: Institutional Review Board
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|University of California Davis Cancer Center||Sacramento, California 95817|