Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers

Phase 2

Terminated

• Conditions: Squamous Cell Carcinoma of Anal Canal
• Interventions: Drug: Nimotuzumab; Radiation: Intensity Modulated Radiation Therapy (IMRT)

• Registration Number: NCT01382745
• Lead Sponsor: Dr. Te Vuong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-24
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Study Start: 2012-01
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-25
• Last Update Posted: 2013-01-28
• Primary Completion: 2021-09
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nimotuzumab	Nimotuzumab	Patients will receive weekly injections of Nimotuzumab (200mg/injection) for 12 weeks and standard external beam radiotherapy
Nimotuzumab	Intensity Modulated Radiation Therapy (IMRT)	Patients will receive weekly injections of Nimotuzumab (200mg/injection) for 12 weeks and standard external beam radiotherapy

Primary Outcome Measures

Name	Time	Method
Toxicity	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.
Local tumor response rate	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.

Secondary Outcome Measures

Name	Time	Method
Overall cancer-free survival	5 years post end of treatment
Overall survival	5 years post end of treatment

Trial Locations

Locations (1)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada