The purpose of this study is to determine that ABX-EGF, using the proposed regimen, will safely increase progression free survival in subjects with metastatic colorectal cancer who have failed available treatment options (i.e., subjects who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy.)

Condition	Intervention	Phase
Colorectal Cancer Metastases	Drug: ABX-EGF	Phase III

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
• ECOG performance status 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
• Unidimensionally measurable disease
• Tumor expressing EGFr by immunohistochemistry
• At least 2 but not more than 3 prior chemotherapy regimens for colorectal cancer
• Adequate hematologic, renal and hepatic function

Exclusion Criteria:

• Symptomatic brain metastases requiring treatment
• History or evidence of interstitial pneumonitis or pulmonary fibrosis
• Use of systemic chemotherapy or radiotherapy within 30 days prior to enrollment
• Prior EGFr targeting therapies
• Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than a week) serum half life within 30 days before enrollment, or prior experimental or approved proteins within 3 months before enrollment

Study ID Numbers:  20020408
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 10, 2005
ClinicalTrials.gov Identifier:  NCT00113763
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05