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Gemcitabine Hydrochloride, Oxaliplatin, and Erlotinib Hydrochloride in Treating Patients With Advanced Biliary Tract Cancer, Pancreatic Cancer, Duodenal Cancer, or Ampullary Cancer

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ClinicalTrials.gov Identifier: NCT00987766
Recruitment Status : Completed
First Posted : October 1, 2009
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center

Study Description
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Brief Summary:

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

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib Trial of Gemcitabine and Oxaliplatin (GEMOX) With Erlotinib in Patients With Advanced Biliary Tract Cancer.
Study Start Date : November 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Maximum tolerated dose and recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin [ Time Frame: 28 days ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987766


Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Laura Goff, MD Vanderbilt-Ingram Cancer Center
More Information
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Additional Information:
Vanderbilt-Ingram Cancer Center, Find a Clinical Trial  This link exits the ClinicalTrials.gov site

Responsible Party: Laura W. Goff, MD, Assistant Professor of Medicine; Associate Director, Hematology/Oncology Fellowship Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00987766     History of Changes
Other Study ID Numbers: VICC GI 0906
P30CA068485 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2009    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017

Keywords provided by Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center:
advanced adult primary liver cancer
stage III pancreatic cancer
stage IV pancreatic cancer
periampullary adenocarcinoma
small intestine adenocarcinoma
 adenocarcinoma of the extrahepatic bile duct
adenocarcinoma of the gallbladder
unresectable extrahepatic bile duct cancer
unresectable gallbladder cancer

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Liver Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
Biliary Tract Neoplasms
Intestinal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
 Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Liver Diseases
Biliary Tract Diseases
Gallbladder Diseases
Bile Duct Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Intestinal Diseases
Gemcitabine
Erlotinib Hydrochloride
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites