Overview

Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers

Status:
Terminated
Trial end date:
2022-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dr. Te Vuong
Collaborator:
YM BioSciences
Treatments:
Nimotuzumab
Criteria
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