Clinical trial NCT01382745: Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of Anal Canal
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: YM BioSciences
First posted: 2011-06-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Toxicity
timeFrame: 1 month post end of treatment
measure: Local tumor response rate
timeFrame: 8 weeks post end of radiation treatment
Secondary outcomes:
measure: Overall cancer-free survival
timeFrame: 5 years post end of treatment
measure: Overall survival
timeFrame: 5 years post end of treatment
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Te Vuong, MD
role: PRINCIPAL_INVESTIGATOR
References: