An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer

NCT ID: NCT00207155

Last Updated: 2015-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2006-02-28

Brief Summary

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The purpose of this study is to predict response to Erbitux as a single agent in patients with metastatic colon cancer

Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Cetuximab

Intervention Type DRUG

IV solution, IV, 400 mg/m2 initial dose + 250-400 mg/m2 weekly, Weekly, Until disease progression.

Interventions

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Cetuximab

IV solution, IV, 400 mg/m2 initial dose + 250-400 mg/m2 weekly, Weekly, Until disease progression.

Intervention Type DRUG

Other Intervention Names

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Erbitux

Eligibility Criteria

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Inclusion Criteria

* Measurable disease Tumor available for biopsies. Life expectancy of at least 3 months.

Exclusion Criteria

* Known or documented brain metastases prior to Cetuximab therapy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Local Institution

Duarte, California, United States

Site Status

Local Institution

Tampa, Florida, United States

Site Status

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Baltimore, Maryland, United States

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St Louis, Missouri, United States

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New Brunswick, New Jersey, United States

Site Status

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The Bronx, New York, United States

Site Status

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Hershey, Pennsylvania, United States

Site Status

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Philadelphia, Pennsylvania, United States

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Nashville, Tennessee, United States

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San Antonio, Texas, United States

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Montreal, Quebec, Canada

Site Status

Local Institution

Barcelona, , Spain

Site Status

Countries

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United States Canada Spain

Other Identifiers

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CA225-045

Identifier Type: -

Identifier Source: org_study_id

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