S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Southwest Oncology Group

ClinicalTrials.gov Identifier:

NCT00096031

First received: November 9, 2004

Last updated: April 4, 2012

Last verified: April 2012

History of Changes

Results First Received: April 4, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Esophageal Cancer
Intervention:	Biological: cetuximab

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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	250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.

Participant Flow: Overall Study

	Cetuximab
STARTED	63
Eligible	57
Eligible and Began Protocol Therapy	55
COMPLETED	0
NOT COMPLETED	63
Adverse Event	3
Lack of Efficacy	42
Death	4
Withdrawal by Subject	1
Ineligible	8
Not protocol specified	5

Baseline Characteristics

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Reporting Groups

	Description
Cetuximab	250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.

Baseline Measures

	Cetuximab
Number of Participants [units: participants]	55
Age [units: years] Median ( Full Range )	61.2 ( 30.7 to 88.5 )
Gender [units: participants]
Female	6
Male	49
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	0
Not Hispanic or Latino	49
Unknown or Not Reported	6
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	1
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	54
More than one race	0
Unknown or Not Reported	0

Outcome Measures

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1. Primary:

Overall Survival at 6 Months [ Time Frame: every 3 weeks while on treatment, then every 3 months ]

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2. Secondary:

Time to Treatment Failure [ Time Frame: every 3 weeks while on treatment ]

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3. Secondary:

Time to Progression [ Time Frame: every 3 weeks while on treatment, then every 3 months for 3 years ]

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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 NOT 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.

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: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623

Publications of Results:

Gold PJ, Goldman B, Iqbal S, et al.: Cetuximab as second-line therapy in patients with metastatic esophageal cancer: a phase II Southwest Oncology Group study. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-96, 2008.

Responsible Party:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00096031 History of Changes
Other Study ID Numbers:	CDR0000391201, S0415, U10CA032102
Study First Received:	November 9, 2004
Results First Received:	April 4, 2012
Last Updated:	April 4, 2012
Health Authority:	United States: Federal Government

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