NCT00493857

Study of Nimotuzumab and Irinotecan in Metastatic Colorectal Cancer

A Phase II Open-Label, 2-Cohort Study of Nimotuzumab 400 mg Weekly Plus Irinotecan (Cohort 1) and Nimotuzumab 400 mg Every 2 Weeks Plus Irinotecan (Cohort 2) in Patients With Irinotecan-Refractory Metastatic Colorectal Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: YM BioSciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Nimotuzumab Humanized Monoclonal Antibody	Nimotuzumab 400mg every week
DRUG	Nimotuzumab	Nimotuzumab 400mg every 2 weeks

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-08-01
• Completion: 2008-12-01
• First posted: 2007-06-28
• Last updated: 2008-11-17

Locations

12 sites across 1 country: Canada