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Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers

This study has been terminated.
(low recruitment)
Sponsor:
Collaborator:
YM BioSciences
Information provided by (Responsible Party):
Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT01382745
First received: June 24, 2011
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Squamous Cell Carcinoma of Anal Canal
 Drug: Nimotuzumab
Radiation: Intensity Modulated Radiation Therapy (IMRT)
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Sir Mortimer B. Davis - Jewish General Hospital:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 1 month post end of treatment ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 8 weeks post end of radiation treatment ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 years post end of treatment ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 5 years post end of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: January 2012
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382745

Locations
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Dr. Te Vuong
YM BioSciences
Investigators
Principal Investigator: Te Vuong, MD Jewish General Hospital
  More Information

No publications provided

Responsible Party: Dr. Te Vuong, MD-Director Radiation Oncology, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT01382745     History of Changes
Other Study ID Numbers: 11-044
Study First Received: June 24, 2011
Last Updated: January 25, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on May 16, 2013