Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or Adenoma

Part of paid clinical trials in Long Beach, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00754494
Phase
PHASE2
Status
Completed

Conditions

  • Adenomatous Polyp
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage I Colon Cancer
  • Stage I Rectal Cancer
  • Stage IIA Colon Cancer
  • Stage IIA Rectal Cancer
  • Stage IIB Colon Cancer
  • Stage IIB Rectal Cancer
  • Stage IIC Colon Cancer
  • Stage IIC Rectal Cancer
  • Stage IIIA Colon Cancer
  • Stage IIIA Rectal Cancer
  • Stage IIIB Colon Cancer
  • Stage IIIB Rectal Cancer
  • Stage IIIC Colon Cancer
  • Stage IIIC Rectal Cancer

Eligibility Criteria

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

Interventions

  • erlotinib hydrochloride — DRUG
    Given PO
  • placebo — OTHER
    Given PO
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This randomized phase II trial is studying how well erlotinib hydrochloride works in treating patients with stage I-III colorectal cancer or adenoma. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Erlotinib hydrochloride may also stop tumors from growing or coming back

Key Dates

First listed
Sep 18, 2008
Start date
Jul 31, 2008
Status verified
Mar 2014
Primary completion
Oct 31, 2012
Completion
Sep 30, 2013

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Erlotinib Hydrochloride (25 mg)
    Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.
  • Experimental: Erlotinib Hydrochloride (50 mg)
    Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.
  • Experimental: Erlotinib Hydrochloride (100 mg)
    Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.

Primary Outcome Measure

Change in ACF pERK Levels [ Time Frame: From baseline to post-treatment (up to 30 days) ]

Locations (3)

FacilityCityStateZIPSite coordinators
VA Long Beach Healthcare SystemLong BeachCalifornia90822-
Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
University of Illinois at ChicagoChicagoIllinois60612-

Find similar trials in Long Beach, CA

By research site
VA Long Beach Healthcare System· Long Beach, CAChao Family Comprehensive Cancer Center· Orange, CAUniversity of Illinois at Chicago· Chicago, IL

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