Gemcitabine and Erlotinib in Treating Patients With Metastatic or Recurrent Pancreatic Cancer (UCDCC#211)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with erlotinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with erlotinib works in treating patients with metastatic or recurrent pancreatic cancer.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Gemcitabine and Intermittent Erlotinib in Advanced Pancreatic Cancer (OSI 4132s)|
- Response rate (partial response or complete response) and duration of response [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Patients will be followed for survival/progression every three months until documented progression, death or study termination. If a patient is still alive, survival time is censored at the time of last follow-up. ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Gemcitabine and Erlotinib
The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.
Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.
Other Name: TarcevaDrug: gemcitabine
The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.
Other Name: Gemzar
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.
|United States, California|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90089-9181|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Primo N. Lara, MD||University of California, Davis|