Study of Nimotuzumab and Irinotecan in Metastatic Colorectal Cancer
Status:
Terminated
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
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.