Gemcitabine Hydrochloride, Oxaliplatin, And Erlotinib Hydrochloride In Treating Patients With Advanced Biliary Tract Cancer, Pancreatic Cancer, Duodenal Cancer, Or Ampullary Cancer

Study Overview

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.

OBJECTIVES: Primary * 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. Secondary * 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.

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

VICC GI 0906
P30CA068485 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-09-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-06-29
First Submitted that Met QC Criteria 2009-09-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-07-02
First Posted (ACTUAL) 2009-10-01	Results First Posted N/A	Last Verified 2017-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment

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.

Primary Outcome Measures	Measure Description	Time Frame
Maximum tolerated dose and recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin		28 days

Secondary Outcome Measures	Measure Description	Time Frame
Antitumor activity		30 days after completing treatment.
E-cadherin, vimentin, fibronectin, amphiregulin, and Kras status in the tumors and their relationship to response		30 days after completing treatment.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Only advanced carcinomas defined as unresectable or metastatic that are histologically or cytologically confirmed to be biliary tract, pancreas, duodenal, or ampullary carcinomas will be included.
Dose-escalation: Patients > 18 years of age with biopsy-confirmed advanced biliary tract adenocarcinoma, pancreas cancer, duodenal cancer, or ampullary cancer
MTD expansion cohort: Patients > 18 years of age with biopsy-confirmed advanced biliary tract adenocarcinoma only.
No prior chemotherapy or prior EGF receptor inhibitor therapy
Measurable tumor by imaging examination
Performance status (PS) 0-2 on the ECOG performance scale
Have pretreatment bilirubin<2.5x upper limit of normal (ULN), serum creatinine<1.5x ULN, AST and ALT <2.5xULN or in the presence of liver metastasis <5xULN, neutrophils>1500, platelets>100K, hemoglobin >9 g/dL
Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
Have the ability to understand the requirements of the study and provide informed consent

CNS metastases
Uncontrolled infection
Pregnant or nursing women may not participate.
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
Psychiatric illness that would prevent understanding the nature of the investigational therapy and complying with protocol requirements
Patients with > grade 2 neuropathy
Patients with > grade 2 uncontrolled nausea and vomiting despite antiemetics
Any concurrent medical condition that, in the judgment of the investigator, would make the patient an inappropriate candidate for study enrollment
Prior chemotherapy or EGFR inhibitor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Laura Goff, MD, Vanderbilt-Ingram Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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