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

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.

Timeline

Start

2008-07

Primary completion

2013-12

Completion

2014-03

Publications

• Cetina L, Crombet T, Jimenez-Lima R, Zapata S, Ramos M, Avila S, Coronel J, Charco E, Bojalil R, Astudillo H, Bazan B, Duenas-Gonzalez A. A pilot study of nimotuzumab plus single agent chemotherapy as second- or third-line treatment or more in patients with recurrent, persistent or metastatic cervical cancer. Cancer Biol Ther. 2015;16(5):684-9. doi: 10.1080/15384047.2015.1026483.

Drugs

Indications