Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Squamous Cell Carcinoma of Anal Canal

Intervention / Treatment
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* Drug: Nimotuzumab
* Radiation: Intensity Modulated Radiation Therapy (IMRT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 month post end of treatment | 
| Local tumor response rate | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Overall cancer-free survival |  | 5 years post end of treatment | 
| Overall survival |  | 5 years post end of treatment |