Erbitux (Cetuximab) Given Alone to Patients With EGFR-Negative Metastatic Colon or Rectal Cancer That is Refractory to Chemotherapy

This study has been completed.

Study NCT00083720 Information provided by ImClone LLC

First Received: May 28, 2004 Last Updated: November 2, 2009 History of Changes

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Conditions:	Colorectal Neoplasms Metastases Neoplasm
Intervention:	Biological: cetuximab

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 87 patients were enrolled between 22 Oct 2004 and 20 Aug 2007 at nine sites in the USA and four sites in Canada.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Cetuximab	Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes

Participant Flow: Overall Study

[1]	Patients analyzed for efficacy who met the epidermal growth factor receptor (EGFR) negative criteria
[2]	Two patients died prior to receiving cetuximab.

Baseline Characteristics

Reporting Groups

	Description
Cetuximab	Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes

Baseline Measures

	Cetuximab
Number of Participants [units: participants]	85
Age [units: participants]
<=18 years	0
Between 18 and 65 years	42
>=65 years	43
Age [units: years] Mean ± Standard Deviation	64.2 ± 11.41
Gender [units: participants]
Female	26
Male	59
Region of Enrollment [units: participants]
United States	20
Canada	65