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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

Primary Purpose

Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
erlotinib hydrochloride
gemcitabine hydrochloride
oxaliplatin
laboratory biomarker analysis
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Gemcitabine + Oxaliplatin + Erlotinib

Outcomes

Primary Outcome Measures

Maximum tolerated dose and recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin

Secondary Outcome Measures

Antitumor activity
E-cadherin, vimentin, fibronectin, amphiregulin, and Kras status in the tumors and their relationship to response

Full Information

First Posted
September 30, 2009
Last Updated
June 29, 2017
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00987766
Brief Title
Gemcitabine Hydrochloride, Oxaliplatin, and Erlotinib Hydrochloride in Treating Patients With Advanced Biliary Tract Cancer, Pancreatic Cancer, Duodenal Cancer, or Ampullary Cancer
Official Title
Phase Ib Trial of Gemcitabine and Oxaliplatin (GEMOX) With Erlotinib in Patients With Advanced Biliary Tract Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer, Pancreatic Cancer, Periampullary Adenocarcinoma, Small Intestine Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Gemcitabine + Oxaliplatin + Erlotinib
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Intervention Description
Taken daily by mouth for 6 days every other week.
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Description
Given through a vein in the arm 1 time every other week.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
Given through a vein in the arm 1 time every other week.
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Blood and tissue collection.
Primary Outcome Measure Information:
Title
Maximum tolerated dose and recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Antitumor activity
Time Frame
30 days after completing treatment.
Title
E-cadherin, vimentin, fibronectin, amphiregulin, and Kras status in the tumors and their relationship to response
Time Frame
30 days after completing treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Goff, MD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.vicc.org/ct/
Description
Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Learn more about this trial

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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