Spots Global Cancer Trial Database for Study of Nimotuzumab and Irinotecan in Metastatic Colorectal Cancer

Study Description

Brief Summary: This study will determine if nimotuzumab provides a benefit in this type of cancer when given in combination with irinotecan. The study will test: * How long any good effects last. * How bad any side effects are. Objectives: Primary: The primary goal is to assess the Objective Response Rate (ORR) that the combination of irinotecan and nimotuzumab will produce in patients with irinotecan-refractory metastatic colorectal cancer Secondary: * To assess the incidence of Grade 2 or greater acneiform rash or infusion reaction, allergic reaction or anaphylactoid reaction AEs in patients with irinotecan-refractory metastatic colorectal cancer following weekly or 2-weekly nimotuzumab schedules; * To assess Progression-Free Survival (PFS), defined as time from date of randomization until date of disease progression (clinical or radiological) or death due to any cause, for the two nimotuzumab schedules; * To assess the rates and durations of Stable Disease (SD) following weekly or 2-weekly nimotuzumab schedules; * To assess the Time to Disease Progression (TTP) following weekly or 2-weekly nimotuzumab schedules; * To evaluate ORR in patients who are identified as having "primary" irinotecan resistance following weekly or 2-weekly nimotuzumab schedules; * To evaluate Overall Survival (OS) following weekly or 2-weekly nimotuzumab schedules; * To compare the two dosing schedules of nimotuzumab with respect to objective response rates and safety; * To evaluate the overall safety and toxicity profiles of these two dose regimens of nimotuzumab; * To evaluate trough levels and accumulation of nimotuzumab in serum of patients receiving the drug on weekly or 2-weekly regimens.

Detailed Description: The patient will receive nimotuzumab every 2 weeks plus irinotecan. Nimotuzumab will be given at a dose of 400 mg once every 2 weeks for 12 weeks. Irinotecan will be given at the same dose and schedule as the last dose and schedule given during the most recent pre-study irinotecan containing therapy. If the tumour does not show signs of further growth after 12 weeks of treatment, the patient will continue receiving nimotuzumab 400 mg every 2 weeks for up to 18 months or as long as they are getting a benefit from the drug.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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