Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

Part of paid clinical trials in Orange, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00482625
Phase
PHASE2
Status
Terminated

Conditions

  • Intraductal Papillary Mucinous Neoplasm of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage IA Pancreatic Cancer
  • Stage IB Pancreatic Cancer
  • Stage IIA Pancreatic Cancer
  • Stage IIB Pancreatic Cancer
  • Stage III Pancreatic Cancer

Eligibility Criteria

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

Interventions

  • erlotinib hydrochloride — DRUG
    Given PO
  • conventional surgery — PROCEDURE
    Undergo pancreatectomy
  • immunohistochemistry staining method — OTHER
    Correlative studies
  • protein expression analysis — GENETIC
    Correlative studies
  • biopsy — PROCEDURE
    Correlative studies
  • pharmacological study — OTHER
    Correlative studies
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. This phase II trial is studying how well erlotinib hydrochloride works in treating patients with pancreatic cancer that can be removed by surgery

Key Dates

First listed
Jun 5, 2007
Start date
Jun 30, 2007
Status verified
Mar 2014
Primary completion
Feb 28, 2010
Completion
Sep 30, 2013

Study Design

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

Arms

  • Experimental: Treatment (enzyme inhibitor therapy)
    Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.

Primary Outcome Measure

Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment [ Time Frame: Pre-treatment and post-treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Medical Center At Irvine-Orange CampusOrangeCalifornia92868-

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