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Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers

Primary Purpose

Squamous Cell Carcinoma of Anal Canal

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Nimotuzumab
Intensity Modulated Radiation Therapy (IMRT)
Sponsored by
Dr. Te Vuong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of Anal Canal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jewish General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nimotuzumab

Arm Description

Patients will receive weekly injections of Nimotuzumab (200mg/injection) for 12 weeks and standard external beam radiotherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall cancer-free survival
Overall survival

Full Information

First Posted
June 24, 2011
Last Updated
January 25, 2013
Sponsor
Dr. Te Vuong
Collaborators
YM BioSciences
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1. Study Identification

Unique Protocol Identification Number
NCT01382745
Brief Title
Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
low recruitment
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Te Vuong
Collaborators
YM BioSciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Anal Canal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nimotuzumab
Arm Type
Experimental
Arm Description
Patients will receive weekly injections of Nimotuzumab (200mg/injection) for 12 weeks and standard external beam radiotherapy
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Intervention Description
200mg Nimotuzumab once a week for 12 weeks
Intervention Type
Radiation
Intervention Name(s)
Intensity Modulated Radiation Therapy (IMRT)
Intervention Description
IMRT radiation therapy with doses varying from 45Gy-54Gy in 25-30 fractions
Primary Outcome Measure Information:
Title
Toxicity
Description
Toxicity evaluation will include all toxicities occurring while the patient is receiving treatment, and will be monitored using the CTCAE guide version 3.0.
Time Frame
1 month post end of treatment
Title
Local tumor response rate
Description
Tumor response rates will be evaluated using the MRI performed at 8-weeks post end of radiotherapy treatment.
Time Frame
8 weeks post end of radiation treatment
Secondary Outcome Measure Information:
Title
Overall cancer-free survival
Time Frame
5 years post end of treatment
Title
Overall survival
Time Frame
5 years post end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Te Vuong, MD
Organizational Affiliation
Jewish General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers

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