Study of IMC-11F8 in Patients With Colorectal Cancer

Inclusion Criteria:

• Histologically-confirmed, EGFR-detectable or EGFR-undetectable colorectal cancer
• Locally-advanced unresectable or metastatic adenocarcinoma of the colon or rectum
• At least one unidimensional-measurable target lesion by CT scan or MRI; target lesion(s) must not lie within an irradiated area
• Age ≥ 18 years
• Life expectancy of ≥ 6 months
• ECOG performance status ≤ 2 at study entry
• Adequate hematologic function, as evidenced by an ANC ≥ 1.5 x 10^9 L, hemoglobin ≥ 10 g/dL, and platelets ≥ 100 x 10^9/L
• Adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL, AST and ALT ≤ 2.5 x ULN, and alkaline phosphatase ≤ 2.5 x ULN (or 5.0 x ULN in the case of liver metastases)
• Adequate renal function as defined by a serum creatinine ≤ 1.5 x ULN, creatinine clearance ≥ 60 mL/min, or serum albumin ≥ LLN
• Patient's relevant toxicities/effects of prior therapy (surgery/RT) must have recovered to a stable or chronic level
• Patient agrees to use adequate contraception during the study period and for 4 weeks after the last dose of study treatment. Patients must notify the principal investigator if they themselves or their partner becomes pregnant.
• Patient has provided signed informed consent

Exclusion Criteria:

• Has received prior systemic chemotherapy for locally-advanced unresectable or metastatic CRC.
• Has received prior radiotherapy to > 25% of bone marrow
• Has documented and/or symptomatic brain metastases
• Has participated in clinical studies of non-approved experimental agents or procedures within 12 weeks of study entry
• Has received previous therapy with monoclonal antibodies
• Has received previous therapy with any agent that targets the epidermal growth factor receptor
• Has serious concomitant medical conditions including active uncontrolled infection or cardiac disease, which in the opinion of the investigator, could compromise the patient or study.
• On chronic non-topical corticosteroid treatment for > 6 months at doses > 10 mg/day of prednisolone or equivalent before study entry, which in the opinion of the investigator could compromise the patient or the study
• Has a known dihydropyrimidine dehydrogenase deficiency
• Has a known allergy to any of the treatment components
• Has an acute or subacute intestinal occlusion
• Has peripheral neuropathy ≥ grade 2
• Has a history of other malignancies, with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix
• If female, is pregnant (confirmed by urine or serum beta human chorionic gonadotropin test) or breast-feeding
• Has received a prior autologous or allogeneic organ or tissue transplantation
• Has interstitial pneumonia or interstitial fibrosis of the lung
• Has pleural effusion or ascites that causes ≥ grade 2 dyspnea
• Has psychological, familial, sociological, or geographical conditions which do not permit adequate study follow-up, compliance with the protocol, or signature of Informed Consent