A Monoclonal Antibody, Nimotuzumab, as Treatment for Recurrent or Metastatic Cervical Cancer
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
The following is an open label, non comparative, pilot study of palliative treatment as a
second, third line or more of treatment in patients with recurrent, persistent or Metastatic
Cervical Cancer; it has a limited sample of 15 patients with the primary goal of evaluating
the response (defined as: Complete, partial or stable disease) to treatment with a Monoclonal
Antibody, Nimotuzumab, on a weekly basis + CDDP 50mg/m2/BSA as a single agent every 3 weeks
for patients with good renal function (Creatinine clearance => 60) or Gemcitabine 800
mg/m2/BSA in patients with renal failure (Creatinine clearance <60).
Secondary objectives consist of evaluating disease-free survival, overall survival and assess
patient tolerance to treatment with Nimotuzumab.