A Trial of Dalotuzumab in Combination With Irinotecan Versus Cetuximab and Irinotecan for Participants With Metastatic Rectal Cancers (mRC) (MK-0646-025)

Exclusion Criteria

• •Has poorly-controlled diabetes
• •Has received chemotherapy or biological therapy within 2 weeks prior to initial dosing on this study, or whose toxicities from agents administered 2 weeks earlier have not resolved to at least grade 1 or baseline, or who is within 3 weeks from a prior surgery
• •Has received radiotherapy within 2 weeks prior to initial dosing on this study, unless the radiotherapy was for management of pain
• •Is currently participating or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the investigational agent, whichever is longer, of initial dosing on this study
• •Was unable to complete previous course of irinotecan due to intolerable toxicity, other than discontinuation due to fatigue following prolonged administration (\>4 months exposure)
• •Has prior exposure to insulin-like growth factor 1 receptor (IGF-1R) inhibitors or epidermal growth factor receptor (EGFR) inhibitors
• •Has a known central nervous system (CNS) metastases and/or carcinomatous meningitis
• •Has primary CNS tumor
• •Has a history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma; potentially curative therapy with no evidence of that disease for 5 years, deemed low risk for recurrence by treating physician.
• •Is human immunodeficiency virus (HIV)-positive
• •Has active hepatitis B or C infection and is receiving antiviral treatment regimens
• •Has symptomatic ascites or pleural effusion
• •Is concurrently using growth hormone (GH), or growth hormone inhibitors