Gemcitabine Hydrochloride, Oxaliplatin, and Erlotinib Hydrochloride in Treating Patients With Advanced Biliary Tract Cancer, Pancreatic Cancer, Duodenal Cancer, or Ampullary Cancer
NCT ID: NCT00987766
Last Updated: 2017-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2009-11-30
2016-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Gemcitabine + Oxaliplatin + Erlotinib
erlotinib hydrochloride
Taken daily by mouth for 6 days every other week.
gemcitabine hydrochloride
Given through a vein in the arm 1 time every other week.
oxaliplatin
Given through a vein in the arm 1 time every other week.
laboratory biomarker analysis
Blood and tissue collection.
Interventions
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erlotinib hydrochloride
Taken daily by mouth for 6 days every other week.
gemcitabine hydrochloride
Given through a vein in the arm 1 time every other week.
oxaliplatin
Given through a vein in the arm 1 time every other week.
laboratory biomarker analysis
Blood and tissue collection.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Laura W. Goff, MD
Assistant Professor of Medicine; Associate Director, Hematology/Oncology Fellowship Program; Medical Oncologist
Principal Investigators
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Laura Goff, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Related Links
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Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
Other Identifiers
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VICC GI 0906
Identifier Type: -
Identifier Source: org_study_id
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