MedTrace Logo

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

NCT00754494 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2015-01-06

Study results available
· View outcomes & findings →

Summary

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

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

Interventions

DRUG

erlotinib hydrochloride

Given PO

OTHER

placebo

Given PO

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Timothy Morgan · Chao Family Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2012-10-31
Completion
2013-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00754494 on ClinicalTrials.gov