A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer

Inclusion Criteria

• Male or female patients, ≥ 18 years of age, able to understand and give written informed consent
• Histologically or cytologically confirmed colorectal adenocarcinoma
• Stage IV (metastatic) disease
• Previously treated with at least one prior irinotecan-containing regimen for colorectal cancer
• Adequate performance status (ECOG 0 or 1) (Appendix 1)
• Expected survival ≥ 6 months
• CEA plasma levels > 5 ng/mL
• Measurable disease by CT or MRI, but with no single lesion measuring more than 10.0 cm
• At least 4 weeks beyond treatment (chemotherapy, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities
• Adequate hematology without ongoing transfusional support (hemoglobin > 8 g/dL, ANC ≥ 1,500 per mm3, platelets > 100,000 per mm3)
• Adequate renal and hepatic function (creatinine ≤ 1.5 x IULN, bilirubin within normal limits, AST and ALT ≤ 3.0 x IULN or 5 x IULN if know liver metastases)
• Otherwise, all acute toxicity at study entry ≤ Grade 1 by NCI CTC v4.0, or recovered to baseline

Exclusion Criteria

• Women who are pregnant or lactating.
• Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
• Patients with Gilbert's disease or known CNS metastatic disease. However, patients with CNS metastases who are asymptomatic and have completed a course of therapy are eligible for the study provided that they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new enlarging CNS metastasis, (2) off steroids or on a stable dose of steroids.
• Patients with CEA plasma levels > 1000 ng/mL must be approved in advance by the Sponsor.
• Patients with active ≥ Grade 3 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
• Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval, or are deemed at low risk for recurrence by his/her treating physician.
• Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
• Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
• Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months.
• Infection requiring intravenous antibiotic use within 1 week.
• Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.