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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00987766
First received: September 30, 2009
Last updated: August 19, 2013
Last verified: August 2013

September 30, 2009
August 19, 2013
November 2009
July 2013   (final data collection date for primary outcome measure)
Maximum tolerated dose and recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Maximum tolerated dose and recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00987766 on ClinicalTrials.gov Archive Site
  • Antitumor activity [ Time Frame: 30 days after completing treatment. ] [ Designated as safety issue: No ]
  • E-cadherin, vimentin, fibronectin, amphiregulin, and Kras status in the tumors and their relationship to response [ Time Frame: 30 days after completing treatment. ] [ Designated as safety issue: No ]
  • Antitumor activity [ Designated as safety issue: No ]
  • E-cadherin, vimentin, fibronectin, amphiregulin, and Kras status in the tumors and their relationship to response [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Liver Cancer
  • Pancreatic Cancer
  • Periampullary Adenocarcinoma
  • Small Intestine Cancer
  • 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.
Experimental: Treatment
Gemcitabine + Oxaliplatin + Erlotinib
Interventions:
  • Drug: erlotinib hydrochloride
  • Drug: gemcitabine hydrochloride
  • Drug: oxaliplatin
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00987766
VICC GI 0906, P30CA068485
Yes
Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Laura Goff, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP