A Monoclonal Antibody, Nimotuzumab, as Treatment for Recurrent or Metastatic Cervical Cancer

Inclusion Criteria

• •Diagnostic criteria:
• •Female patients in whom a diagnosis of cervical cancer of epithelial origin has been confirmed by histologic and/or radiologic assessment.
• •Said patients must be in relapse or persistency after receiving first line chemo-radiotherapy and one or more lines of palliative chemotherapy.
• •Karnofsky score of 80 or more.
• •A CT scan will be performed in all patients to assess measurable target lesions.
• •The clinical diagnosis must be evaluated by more than clinical investigator
• •Patients who give their written consent of participation in this study.
• •Patients with recurrent or persistent cervical-uterine cancer, with local and/or systemic disease with measurable lesions, whether by physical examination, CT Scan or MRI detected at least in the previous 6 weeks. If there is only one lesion and it is less than 10 mm in length, a biopsy confirmation is required.
• •Patients currently receiving a second, third line or more of palliative chemotherapy diagnosed at least 30 days after the last chemotherapy.
• •Patients with one of the following Histopathological reports: Squamous Cell Carcinoma (epidermoid carcinoma), adenocarcinoma, adenosquamous carcinoma or glassy cell carcinoma.
• •Patients must be older than 18 years old.
• •ECOG score no worst than 3.
• •Patients with life expectancy greater than 4 weeks.
• •Patients with left ventricle ejection fraction (LVEF) ≥ 50 measured by radioisotopic ventriculography.
• •Patients who meet all previous criteria with previously radiated metastatic disease in the central nervous system will be included.
• •Patients with normal functioning of the bone marrow and other organs as defined by the following parameters:
• •Hemoglobin ≥ 9 g/L
• •Leucocytes ≥ 4000/microL
• •Absolute neutrophil count ≥ 1500/microL
• •Platelet count ≥ 100000/microL
• •Total serum Bilirubin: up to 1.5 times the normal value
• •Total Proteins: Within normal limits
• •AST and ALT =/\< 2.5 times the normal superior limit of the institutional laboratory
• •Serum creatinine: within normal limits or up to 2 mg and GFR ≥ 60ml/min calculated with the Cockcroft-Gault equation.