Gemcitabine Hydrochloride, Oxaliplatin, and Erlotinib Hydrochloride in Treating Patients With Advanced Biliary Tract Cancer, Pancreatic Cancer, Duodenal Cancer, or Ampullary Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and oxaliplatin together with erlotinib hydrochloride may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with gemcitabine hydrochloride and oxaliplatin in treating patients with advanced biliary tract cancer, pancreatic cancer, duodenal cancer, or ampullary cancer.
Extrahepatic Bile Duct Cancer
Small Intestine Cancer
Drug: erlotinib hydrochloride
Drug: gemcitabine hydrochloride
Other: laboratory biomarker analysis
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase Ib Trial of Gemcitabine and Oxaliplatin (GEMOX) With Erlotinib in Patients With Advanced Biliary Tract Cancer.|
- Maximum tolerated dose and recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Antitumor activity [ Time Frame: 30 days after completing treatment. ] [ Designated as safety issue: No ]
- E-cadherin, vimentin, fibronectin, amphiregulin, and Kras status in the tumors and their relationship to response [ Time Frame: 30 days after completing treatment. ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Gemcitabine + Oxaliplatin + Erlotinib
Drug: erlotinib hydrochloride
Taken daily by mouth for 6 days every other week.Drug: gemcitabine hydrochloride
Given through a vein in the arm 1 time every other week.Drug: oxaliplatin
Given through a vein in the arm 1 time every other week.Other: laboratory biomarker analysis
Blood and tissue collection.
- 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 cancer.
- 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.
|Contact: Vanderbilt-Ingram Cancer Center, Clinical Trials Program||800-811-8480|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Recruiting|
|Nashville, Tennessee, United States, 37064|
|Contact: VICC Clinical Trials Information Program 800-811-8480|
|Vanderbilt-Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37232-6838|
|Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480|
|Principal Investigator:||Laura Goff, MD||Vanderbilt-Ingram Cancer Center|