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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Squamous Cell Carcinoma of Anal Canal

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxicity

Outcome Description:

Toxicity evaluation will include all toxicities occurring while the patient is receiving treatment, and will be monitored using the CTCAE guide version 3.0.

Outcome Time Frame:

1 month post end of treatment

Safety Issue:

Yes

Principal Investigator

Te Vuong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jewish General Hospital

Authority:

Canada: Health Canada

Study ID:

11-044

NCT ID:

NCT01382745

Start Date:

January 2012

Completion Date:

January 2022

Related Keywords:

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

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