Gemcitabine Hydrochloride, Oxaliplatin, and Erlotinib Hydrochloride in Treating Patients With Advanced Biliary Tract Cancer, Pancreatic Cancer, Duodenal Cancer, or Ampullary Cancer
|ClinicalTrials.gov Identifier: NCT00987766|
Recruitment Status : Completed
First Posted : October 1, 2009
Last Update Posted : July 2, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer Pancreatic Cancer Periampullary Adenocarcinoma Small Intestine Cancer||Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride Drug: oxaliplatin Other: laboratory biomarker analysis||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib Trial of Gemcitabine and Oxaliplatin (GEMOX) With Erlotinib in Patients With Advanced Biliary Tract Cancer.|
|Study Start Date :||November 2009|
|Primary Completion Date :||July 2013|
|Study Completion Date :||October 2016|
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.
- Maximum tolerated dose and recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin [ Time Frame: 28 days ]
- Antitumor activity [ Time Frame: 30 days after completing treatment. ]
- E-cadherin, vimentin, fibronectin, amphiregulin, and Kras status in the tumors and their relationship to response [ Time Frame: 30 days after completing treatment. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987766
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Laura Goff, MD||Vanderbilt-Ingram Cancer Center|