The purpose of this study is to determine if 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.

Condition	Treatment or Intervention	Phase
Colorectal Cancer Metastases	Drug: ABX-EGF	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 kinas 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 3 months before enrollment

For additional information regarding investigative sites for trial, contact the Amgen Call Center at:      866-572-6436 

California
      Research Site, Loma Linda,  California,  United States; Recruiting
      Research Site, Redding,  California,  United States; Recruiting
Colorado
      Research Site, Aurora,  Colorado,  United States; Recruiting
      Research Site, Boulder,  Colorado,  United States; Recruiting
      Research Site, Colorado Springs,  Colorado,  United States; Recruiting
      Research Site, Denver,  Colorado,  United States; Recruiting
Connecticut
      Research Site, Stamford,  Connecticut,  United States; Recruiting
      Research Site, Waterbury,  Connecticut,  United States; Recruiting
      Research Site, Norwich,  Connecticut,  United States; Recruiting
District of Columbia
      Research Site, Washington,  District of Columbia,  United States; Recruiting
Florida
      Research Site, Jacksonville,  Florida,  United States; Recruiting
      Research Site, Orange Park,  Florida,  United States; Recruiting
      Research Site, Stuart,  Florida,  United States; Recruiting
Georgia
      Research Site, Atlanta,  Georgia,  United States; Recruiting
      Research Site, Augusta,  Georgia,  United States; Recruiting
Illinois
      Research Site, Chicago,  Illinois,  United States; Recruiting
      Research Site, Harvey,  Illinois,  United States; Recruiting
      Research Site, Libertyville,  Illinois,  United States; Recruiting
      Research Site, Skokie,  Illinois,  United States; Recruiting
Indiana
      Research Site, Noblesville,  Indiana,  United States; Recruiting
      Research Site, Indianapolis,  Indiana,  United States; Recruiting
      Research Site, New Albany,  Indiana,  United States; Recruiting
Michigan
      Research Site, Flint,  Michigan,  United States; Recruiting
Montana
      Research Site, Billings,  Montana,  United States; Recruiting
New Mexico
      Research Site, Santa Fe,  New Mexico,  United States; Recruiting
New York
      Research Site, Bronx,  New York,  United States; Recruiting
      Research Site, New York,  New York,  United States; Recruiting
North Carolina
      Research Site, Charlotte,  North Carolina,  United States; Recruiting
Ohio
      Research Site, Canton,  Ohio,  United States; Recruiting
      Research Site, Columbus,  Ohio,  United States; Recruiting
      Research Site, Westerville,  Ohio,  United States; Recruiting
Oklahoma
      Research Site, Oklahoma City,  Oklahoma,  United States; Recruiting
Pennsylvania
      Research Site, Philadelphia,  Pennsylvania,  United States; Recruiting
      Research Site, Pittsburgh,  Pennsylvania,  United States; Recruiting
Tennessee
      Research Site, Collierville,  Tennessee,  United States; Recruiting
      Research Site, Memphis,  Tennessee,  United States; Recruiting
Texas
      Research Site, Dallas,  Texas,  United States; Recruiting
      Research Site, Lubbock,  Texas,  United States; Recruiting
Utah
      Research Site, Ogden,  Utah,  United States; Recruiting
      Research Site, Salt Lake City,  Utah,  United States; Recruiting
Virginia
      Research Site, Abingdon,  Virginia,  United States; Recruiting
Wisconsin
      Research Site, Madison,  Wisconsin,  United States; Recruiting

Study ID Numbers:  20030250
Record last reviewed:  October 2004
Record first received:  August 9, 2004
ClinicalTrials.gov Identifier:  NCT00089635
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-09