Phase Ib Trial of Gemcitabine and Oxaliplatin (GEMOX) With Erlotinib in Patients With Advanced Biliary Tract Cancer.
- To determine the maximum tolerated dose and the recommended phase II dose of erlotinib
hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin in patients
with advanced biliary tract cancer, pancreatic cancer, duodenal cancer, or ampullary
- To describe any antitumor activity associated with this treatment regimen when given
during the dose-escalation and expanded-cohort portions of this study.
- To evaluate e-cadherin, vimentin, fibronectin, amphiregulin, and Kras status in the
tumors and assess their relationship to response.
OUTLINE: This is a multicenter, dose-escalation study of erlotinib hydrochloride.
Patients receive gemcitabine hydrochloride IV on day 1, oxaliplatin IV over 2 hours on day
2, and oral erlotinib hydrochloride once daily on days 3-8. Courses repeat every 2 weeks in
the absence of disease progression or unacceptable toxicity.
Tumor tissue samples are collected for biomarker and other analysis.
After completion of study treatment, patients are followed up for 30 days.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose and recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin
Laura Goff, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC GI 0906
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Nashville, Tennessee 37064|