Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers

Squamous Cell Carcinoma of Anal Canal Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01382745
• Other study ID #: 11-044
• Status: Terminated
• Phase: Phase 2
• First received: June 24, 2011
• Last updated: January 25, 2013
• Start date: January 2012
• Est. completion date: January 2022

Study information

• Verified date: January 2013
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Anus Neoplasms
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Anal Canal

Intervention

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

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Te Vuong	YM BioSciences

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	Overall cancer-free survival		5 years post end of treatment	Yes
Secondary	Overall survival		5 years post end of treatment	Yes