Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers

January 25, 2013 updated by: Dr. Te Vuong

A Phase II Clinical Study Using Nimotuzumab in Combination With External Beam Radiation Therapy in the Treatment of Patients With Carcinomas of the Anal Canal

The objective of this study is to demonstrate the feasibility of using Nimotuzumab and radiation in the treatment of squamous cell carcinomas of the anal canal in order to achieve a 65% local control rate with a better toxicity profile than the conventional treatment. Patients with high toxicity risks (HIV+ and fragile patients) will be selected for this study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

For both step I and II:

  • Patients with histologically confirmed squamous cell carcinoma of the anal canal
  • Aged 18 years or older
  • ECOG: 0-1-2
  • Adequate contraception in women of child-bearing potential and for men
  • Ability to understand and the willingness to sign a written informed consent document.
  • HIV-positive patients with T1-2 anal canal tumors, or
  • Patients with anal canal tumors not eligible for conventional chemotherapy (for example, due to age and/or co-morbidities)
  • Patients who have already started radiotherapy for anal canal cancer

For step II:

  • HIV-positive patients with T1, T2 anal canal tumors
  • HIV-negative patients not eligible for conventional chemotherapy (for example, due to age and/or co-morbidities)
  • HIV-negative patients with T1-2 anal canal cancer

Exclusion Criteria:

For both step I and II:

  • Patients receiving any other investigational agents
  • Previous treatment with anti-EGFR drugs
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nimotuzumab or other agents used in study.
  • Previously treated with pelvic radiotherapy.
  • Lesions not suitable for radiotherapy
  • Patients with uncontrolled hypercalcemia
  • Uncontrolled intercurrent illness
  • Pregnant or breast-feeding women
  • Any concurrent active malignancy
  • Patients with T3-4 anal canal tumors or patients with nodes positive.

Step I:

  • HIV-negative patients with anal canal tumors that are judged suitable for current treatment consisting in radiotherapy and 5-FU and MMC chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nimotuzumab
Patients will receive weekly injections of Nimotuzumab (200mg/injection) for 12 weeks and standard external beam radiotherapy
Drug: Nimotuzumab
200mg Nimotuzumab once a week for 12 weeks
Radiation: Intensity Modulated Radiation Therapy (IMRT)
IMRT radiation therapy with doses varying from 45Gy-54Gy in 25-30 fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity
Time Frame: 1 month post end of treatment
Toxicity evaluation will include all toxicities occurring while the patient is receiving treatment, and will be monitored using the CTCAE guide version 3.0.
1 month post end of treatment
Local tumor response rate
Time Frame: 8 weeks post end of radiation treatment
Tumor response rates will be evaluated using the MRI performed at 8-weeks post end of radiotherapy treatment.
8 weeks post end of radiation treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall cancer-free survival
Time Frame: 5 years post end of treatment
5 years post end of treatment
Overall survival
Time Frame: 5 years post end of treatment
5 years post end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Te Vuong

Collaborators

YM BioSciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

June 24, 2011

First Submitted That Met QC Criteria

June 24, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 25, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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