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