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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT00987766
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib hydrochloride — DRUG
    Taken daily by mouth for 6 days every other week.
  • gemcitabine hydrochloride — DRUG
    Given through a vein in the arm 1 time every other week.
  • oxaliplatin — DRUG
    Given through a vein in the arm 1 time every other week.
  • laboratory biomarker analysis — OTHER
    Blood and tissue collection.

Study Details

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.

Key Dates

First listed
Oct 1, 2009
Start date
Nov 30, 2009
Status verified
Jun 2017
Primary completion
Jul 31, 2013
Completion
Oct 31, 2016

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Gemcitabine + Oxaliplatin + Erlotinib

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-6838-

Find similar trials in Nashville, TN

By condition
Liver cancerPancreatic cancer
By specialty
OncologyGI oncologyHepatology
By research site
Vanderbilt-Ingram Cancer Center· Nashville, TN

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