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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

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

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

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.

Inclusion Criteria

Inclusion Criteria

- Confirmed colorectal cancer with metastatic disease documented on diagnostic imaging

- Measurable disease,

- Must have clinical documentation of failure after receiving at least one chemotherapy
regimen for metastatic disease that contained irinotecan.

- Must have documentation of failure by CT, MRI or PET scan. Patients who were
intolerant of irinotecan despite dose attenuations are not eligible for this trial.

- Patients must have failed irinotecan which they received on one of the following
three starting regimens:Weekly,Biweekly or every 3 weeks. mg/m2.

6.Patients may have received any number of prior standard and investigational
regimens or radiation treatments, provided that they meet all other eligibility

- Age greater than 18 years.

- Life expectancy of greater than 3 months.

- ECOG performance status less than 1

- Patients must have normal organ and marrow function

- Patients must have medical documentation of dose, schedule, and dates of last
irinotecan administration.

- Women of child-bearing potential and men must agree to use adequate contraception

- Patients must have the ability to understand and the willingness to sign a written
informed consent document.

Subject Exclusion Criteria

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier.
Neurotoxicity, if present, must have recovered to < grade 2.

- No other investigational agents.

- No known brain metastases.Patients with a history of primary CNS tumours, seizures
not well controlled with standard medical therapy, or history of stroke will also be

- History of allergic reactions attributed to compounds of chemical or biologic
composition similar to nimotuzumab, irinotecan, or other agents used in the study.

- Previous EGFR-directed therapy

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection requiring parenteral antibiotics, symptomatic congestive heart failure,
unstable angina pectoris, uncontrolled hypertension, clinically significant cardiac
arrhythmia, history of myocardial infarction within the past 6 months, or psychiatric
illness/social situations that would limit compliance with study requirements.

- HIV-positive patients on combination antiretroviral therapy are ineligible

- Active cardiovascular disease, e.g., uncontrolled hypertension, unstable angina, New
York Heart Association grade II or greater congestive heart failure, serious cardiac
arrhythmia requiring medications, or grade II or greater peripheral vascular disease.
In addition, patients with arterial thrombosis, myocardial infarction, and cerebral
vascular accidents [stroke/transient ischemic attack (TIA)] within 6 months prior to
study entry will be excluded.

- Organ allografts requiring immunosuppressive therapy. -.Pregnant or lactating women
are excluded from this study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

18-24 months

Principal Investigator

Amil Shah, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vancouver Cancer Centre BC cancer Agency


Canada: Health Canada

Study ID:

YMB 1000-015



Start Date:

June 2007

Completion Date:

December 2008

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer
  • Monoclonal antibody
  • Anti-EGFR
  • Colorectal Neoplasms