Trial | NCT01382745  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    nimotuzumab ...

  • Study Participants

    1
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.
Study Started
Jan 31
2012
Primary Completion
Sep 30
2021
Anticipated
Study Completion
Jan 31
2022
Anticipated
Last Update
Jan 28
2013
Estimate

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

Nimotuzumab Experimental

Patients will receive weekly injections of Nimotuzumab (200mg/injection) for 12 weeks and standard external beam radiotherapy

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
No Results Posted