Study of Nimotuzumab and Irinotecan in Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00493857
- Lead Sponsor
- YM BioSciences
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 2 Nimotuzumab Humanized Monoclonal Antibody Nimotuzumab 400mg every week or every two weeks 2 Nimotuzumab Nimotuzumab 400mg every week or every two weeks
- Primary Outcome Measures
Name Time Method 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 18-24 months
- Secondary Outcome Measures
Name Time Method Assess the incidence of acneiform rash,drug reaction,adverse events, the assessment of progression-free survival,stable disease,time to disease progression, overall survival, objective response rates, safety and trough levels in the serum of patients. 18-24 months
Trial Locations
- Locations (12)
Tom Baker Cancer Center
🇨🇦Calgary, Alberta, Canada
Dr. H. Bliss Purphy Cancer Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
Royal Victoria Hospital
🇨🇦Barrie, Ontario, Canada
London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Cancer Care Program Southlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada
Grand River Hospital
🇨🇦Kitchener, Ontario, Canada
Credit Valley Hospital /Carlo Fidani Peel Regional Cancer Centre
🇨🇦Mississauga, Ontario, Canada
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Algoma District Cancer Care Program
🇨🇦Sault Ste Marie, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Cancer Care Manitoba
🇨🇦Winnipeg, Manitoba, Canada