NCT00207155

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2003

Typical duration for phase_1

Geographic Reach
3 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

2.2 years

First QC Date

September 12, 2005

Last Update Submit

October 26, 2015

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Prediction of response to Erbitux in subjects with metastatic colorectal cancer

Secondary Outcomes (1)

  • Radiographic Response

Study Arms (1)

A

EXPERIMENTAL
Drug: Cetuximab

Interventions

CetuximabDRUG

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

Also known as: Erbitux
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Known or documented brain metastases prior to Cetuximab therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Local Institution

Duarte, California, United States

Location

Local Institution

Tampa, Florida, United States

Location

Local Institution

Baltimore, Maryland, United States

Location

Local Institution

St Louis, Missouri, United States

Location

Local Institution

New Brunswick, New Jersey, United States

Location

Local Institution

The Bronx, New York, United States

Location

Local Institution

Cincinnati, Ohio, United States

Location

Local Institution

Cleveland, Ohio, United States

Location

Local Institution

Hershey, Pennsylvania, United States

Location

Local Institution

Philadelphia, Pennsylvania, United States

Location

Local Institution

Nashville, Tennessee, United States

Location

Local Institution

San Antonio, Texas, United States

Location

Local Institution

Montreal, Quebec, Canada

Location

Local Institution

Barcelona, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 21, 2005

Study Start

December 1, 2003

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

October 28, 2015

Record last verified: 2015-10

Locations

US(12)CA(1)ES(1)