An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer
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