09PAN01 Study Summary
PROTOCOL SUMMARY:
Title:
A Phase 1b Study of Erlotinib in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Previously Untreated Advanced Pancreatic Cancer
Primary Objective:
To define the maximum tolerated dose (MTD) for the combination of gemcitabine, nab-paclitaxel, and erlotinib
Secondary Objectives:
To assess the safety of the combination of gemcitabine, nab-paclitaxel, and erlotinib.
To evaluate limited erlotinib pharmacokinetic profiling in combination with gemcitabine and nab-paclitaxel.
To perform a preliminary evaluation of efficacy of the 3-drug combination (objective response rate, progression-free survival, and overall survival).
Target Population:
Patients with untreated, locally advanced, unresectable or metastatic adenocarcinoma of the pancreas.
Rationale for Drug Combination:
The standard chemotherapy treatment for advanced pancreatic cancer is gemcitabine. Recently, there has been encouraging preliminary activity with the combination of gemcitabine and nab-paclitaxel in advanced pancreatic cancer. In addition, a study has shown statistically significant survival benefit of adding erlotinib to gemcitabine in advanced pancreatic cancer. Although erlotinib in combination with gemcitabine results in an overall survival benefit, the preliminary results with the combination of gemcitabine and nab-paclitaxel warrant further testing with the addition of erlotinib to these agents.
Planned Enrollment Period:
January 2010- October 2010
Study Contact Information:
General AGICC contact:
Patricia Ames: (323) 966-3564
Site Specific contacts:
See site listings below.
For more detailed study information, see www.clinicaltrials.gov trial identifier: NCT01010945.
This clinical research trial is open or will be opening at the following AGICC sites:
Comprehensive Cancer Center at Desert Regional Medical Center
PI: Lawrence P. Leichman, MD
Phone Number: (760) 416-4734
Comprehensive Cancer Center at Desert Regional Medical Center
PI: Lawrence P. Leichman, MD
Phone Number: (760) 416-4734
Fox Chase Cancer Center
PI: Steven J. Cohen, MD
Phone Number: (215) 728-5623
University of North Carolina Lineberger Comprehensive Cancer Center
PI: Bert H. O'Neil, MD
Phone Number: (919) 843-7115
Vanderbilt-Ingram Cancer Center, Vanderbilt University
PI: Jordan D. Berlin, MD
Phone Number: (615) 936-5786
University of Colorado Cancer Center
PI: Wells A. Messersmith, MD
Phone Number: (720) 848-5494
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