MedTrace Logo

Study of Nimotuzumab and Irinotecan in Metastatic Colorectal Cancer

NCT00493857 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2008-11-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Nimotuzumab Humanized Monoclonal Antibody

Nimotuzumab 400mg every week

DRUG

Nimotuzumab

Nimotuzumab 400mg every 2 weeks

Sponsors & Collaborators

  • YM BioSciences

    lead INDUSTRY

Principal Investigators

  • Amil Shah, MD · Vancouver Cancer Centre BC cancer Agency

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-08-31
Completion
2008-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00493857 on ClinicalTrials.gov