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ABX-EGF Monotherapy in Subjects with Metastatic Colorectal Cancer
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Age
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Protocol IDs
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Phase II
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Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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20030250
NCT00089635
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Trial Description
Summary The purpose of this study is to determine that ABX-EGF will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy. Eligibility Criteria Inclusion Criteria: - Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
- Metastatic colorectal carcinoma
- Eastern Cooperative Oncology Group of 0, 1 or 2
- Documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer
- Radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen is required
- Bidimensionally measurable disease
- Tumor expressing low to negative levels of EGFr by immunohistochemistry
- At least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal cancer
- Adequate hematologic, renal and hepatic function
Exclusion Criteria: - Symptomatic brain metastases requiring treatment
- Patient with a history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis
- Use of systemic chemotherapy or radiotherapy within 30 days before enrollment
- Prior anti-EGFr antibody therapy with the exception of the small molecule EGFr tyrosine kinase inhibitors, which are permitted
- Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than 1 week) serum half-life within 30 days before enrollment, or prior experimental or approved proteins within 6 weeks before enrollment
Trial Contact Information
Trial Lead Organizations/Sponsors Amgen, Incorporated | For additional information regarding investigative sites for trial, contact the Amgen Call Center at: | | Ph: 866-572-6436 |
Trial Sites
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| Arizona |
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Lake Havasu City |
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| California |
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Burbank |
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Loma Linda |
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Los Angeles |
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Redding |
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| Colorado |
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Aurora |
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Boulder |
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Colorado Springs |
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Denver |
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Littleton |
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| Connecticut |
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Norwich |
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Stamford |
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Waterbury |
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| District of Columbia |
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Washington |
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| Florida |
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Jacksonville |
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Orange Park |
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Stuart |
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| Georgia |
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Atlanta |
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Augusta |
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| Idaho |
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Boise |
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| Illinois |
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Chicago |
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Harvey |
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Libertyville |
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Skokie |
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| Indiana |
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Indianapolis |
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New Albany |
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Noblesville |
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| Kentucky |
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Paducah |
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| Maryland |
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Baltimore |
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| Michigan |
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Flint |
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St. Joseph |
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| Montana |
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Billings |
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| Nevada |
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Reno |
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| New Mexico |
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Albuquerque |
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Santa Fe |
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| New York |
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Bronx |
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Fresh Meadows |
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New York |
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| North Carolina |
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Charlotte |
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| Ohio |
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Canton |
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Columbus |
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Westerville |
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| Oklahoma |
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Oklahoma City |
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| Pennsylvania |
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Philadelphia |
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Pittsburgh |
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| South Carolina |
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Charleston |
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Hilton Head |
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| Tennessee |
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Collierville |
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Memphis |
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Nashville |
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| Texas |
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Amarillo |
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Austin |
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Dallas |
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Lubbock |
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| Utah |
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Ogden |
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Salt Lake City |
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| Virginia |
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Abingdon |
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| Wisconsin |
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Madison |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00089635
Information obtained from ClinicalTrials.gov on 2005-05-20 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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