Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-24 @ 6:30 PM
NCT ID:
NCT00493857
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.
Study:
NCT00493857
Study Brief:
Protocol Section:
NCT00493857