Gemcitabine Hydrochloride, Oxaliplatin, and Erlotinib Hydrochloride in Treating Patients With Advanced Biliary Tract Cancer, Pancreatic Cancer, Duodenal Cancer, or Ampullary Cancer
Phase Ib Trial of Gemcitabine and Oxaliplatin (GEMOX) With Erlotinib in Patients With Advanced Biliary Tract Cancer.
2 other identifiers
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2009
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2009
CompletedFirst Posted
Study publicly available on registry
October 1, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJuly 2, 2017
June 1, 2017
3.7 years
September 30, 2009
June 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose and recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin
28 days
Secondary Outcomes (2)
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.
Study Arms (1)
Treatment
EXPERIMENTALGemcitabine + Oxaliplatin + Erlotinib
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Goff, MD
Vanderbilt-Ingram Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine; Associate Director, Hematology/Oncology Fellowship Program; Medical Oncologist
Study Record Dates
First Submitted
September 30, 2009
First Posted
October 1, 2009
Study Start
November 1, 2009
Primary Completion
July 1, 2013
Study Completion
October 1, 2016
Last Updated
July 2, 2017
Record last verified: 2017-06