Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers

Dr. Te Vuong

Status and phase: Terminated; Phase 2

Conditions: Squamous Cell Carcinoma of Anal Canal

Treatments: Radiation: Intensity Modulated Radiation Therapy (IMRT); Drug: Nimotuzumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01382745

11-044

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Nimotuzumab

Experimental group

Description:

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

Treatment:

Radiation: Intensity Modulated Radiation Therapy (IMRT)

Drug: Nimotuzumab