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
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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

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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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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Time Frame	Adverse events were collected from the time that the patient received the initial cetuximab infusion and continued during the study until 30 days after the last dose of cetuximab.
Additional Description	The NCI-CTCAE V3.0 toxicity criteria was used to grading the severity of all AEs.

Frequency Threshold

Threshold above which other adverse events are reported	5%

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

Other Adverse Events

	Cetuximab
Total, other (not including serious) adverse events
# participants affected / at risk	84
Gastrointestinal disorders
Abdominal pain ^†^A # participants affected / at risk # events	8/85 (9.41%) 8
Constipation ^†^A # participants affected / at risk # events	8/85 (9.41%) 11
Diarrhea ^†^A # participants affected / at risk # events	12/85 (14.12%) 17
Nausea ^†^A # participants affected / at risk # events	13/85 (15.29%) 14
Stomatitis ^†^A # participants affected / at risk # events	9/85 (10.59%) 10
Vomiting ^†^A # participants affected / at risk # events	8/85 (9.41%) 11
General disorders
Chills ^†^A # participants affected / at risk # events	6/85 (7.06%) 8
Fatigue ^†^A # participants affected / at risk # events	27/85 (31.76%) 33
Oedema peripheral ^†^A # participants affected / at risk # events	6/85 (7.06%) 6
Pyrexia ^†^A # participants affected / at risk # events	6/85 (7.06%) 6
Metabolism and nutrition disorders
Anorexia ^†^A # participants affected / at risk # events	20/85 (23.53%) 21
Hypomagnesaemia ^†^A # participants affected / at risk # events	10/85 (11.76%) 14
Musculoskeletal and connective tissue disorders
Back pain ^†^A # participants affected / at risk # events	6/85 (7.06%) 7
Nervous system disorders
Headache ^†^A # participants affected / at risk # events	25/85 (29.41%) 28
Respiratory, thoracic and mediastinal disorders
Cough ^†^A # participants affected / at risk # events	5/85 (5.88%) 6
Dyspnea ^†^A # participants affected / at risk # events	6/85 (7.06%) 7
Epistaxis ^†^A # participants affected / at risk # events	5/85 (5.88%) 6
Skin and subcutaneous tissue disorders
Dermatitis acneiform ^†^A # participants affected / at risk # events	73/85 (85.88%) 102
Dry skin ^†^A # participants affected / at risk # events	15/85 (17.65%) 16
Nail disorder ^†^A # participants affected / at risk # events	9/85 (10.59%) 12
Pruritus ^†^A # participants affected / at risk # events	6/85 (7.06%) 7
Skin disorder ^†^A # participants affected / at risk # events	6/85 (7.06%) 7

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA 10.0

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
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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