Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01382745

Enrollment

Registered

2011-06-27

Start date

2012-01-31

Completion date

2022-01-31

Last updated

2013-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Carcinoma of Anal Canal

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.

Interventions

DRUGNimotuzumab

200mg Nimotuzumab once a week for 12 weeks

RADIATIONIntensity Modulated Radiation Therapy (IMRT)

IMRT radiation therapy with doses varying from 45Gy-54Gy in 25-30 fractions

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Overall cancer-free survival	5 years post end of treatment
Overall survival	5 years post end of treatment

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026