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

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

	Cetuximab
STARTED	85^[1]
COMPLETED	85^[2]
NOT COMPLETED	0

[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

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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

Outcome Measures

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1. Primary:

Percentage of Participants With an Overall Resonse [ Tumor evaluations were performed at a minimum every 6 weeks while on cetuximab therapy until progressive disease (PD) or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation. ]

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2. Primary:

Number of Participants With Adverse Events [ An adverse event (AE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab. ]

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Measure Type	Primary
Measure Title	Number of Participants With Adverse Events
Measure Description	Reported adverse events (AEs) per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for Regulatory Activities dictionary. The National Cancer Insititute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 was used to grade all AEs. The collection of AEs began at the time the patient received the first cetuximab dose and continued during the study until 30 days after the last dose of cetuximab. All patients who were enrolled and treated with cetuximab were assessed for safety (mITT population, as treated).
Time Frame	An adverse event (AE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients who were enrolled and treated with any quantity of cetuximab constitute the mITT population. Since this trial was a single arm trial, the mITT population used for the efficacy analyses was also used for the safety analyses.

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

Measured Values

	Cetuximab
Number of Participants Analyzed [units: participants]	85
Number of Participants With Adverse Events [units: Participants]	85

No statistical analysis provided for Number of Participants With Adverse Events

3. Primary:

Number of Participants With Serious Adverse Events [ A serious adverse event (SAE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab. ]

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4. Secondary:

Percentage of Participants With Disease Control (CR, PR, or SD) [ Tumor evaluations were performed at a minimum of every 6 weeks while on cetuximab therapy. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response. ]

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5. Secondary:

Duration of Response [ The duration of response was measured from the date of response to the first date of PD (range 2 to 7 months). ]

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6. Secondary:

Time to Progression [ Patients with PD after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine (range: 1-3 months). ]

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7. Secondary:

Overall Survival [ Survival information was collected every 3 months after completion of therapy and/or follow-up up to 24 months. ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Investigators may not independently publish/disclose any study data, findings or conclusions except as part of an overall multi-center publication. After final publication, or if a draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to review for sponsor confidential information which may be redacted at sponsor request. Publication may be delayed up to 90 days to seek patent protection.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: HagopYoussoufian, SVP, Clinical Research
Organization: ImClone LLC
phone: 908 541 8287
e-mail: Hagop.Youssoufian@ImClone.com

No publications provided

Responsible Party:	ImClone LLC ( Eric Rowinsky/ Chief Medical Officer )
Study ID Numbers:	CP02-0451
Study First Received:	May 28, 2004
Results First Received:	April 16, 2009
Last Updated:	November 2, 2009
ClinicalTrials.gov Identifier:	NCT00083720 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Ethics Review Committee; Canada: Health Canada