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.

Conditions

• Uterine Cervical Cancer

Interventions

DRUG

Nimotuzumab

Monoclonal antibody Nimotuzumab will be administered alone at a 200mg dose weekly during the first 4 weeks. Posteriorly it will be administered with a maintenance dose of 200 mg every 2 weeks in combination with chemotherapeutic agents Cisplatin in patients with good renal function or Gemcitabine in patients with kidney failure data until exclusion or death occurs. The administration will be intravenously in 250 ml of saline solution in a time period of 30 minutes.

DRUG

Cisplatin

Cisplatin will be administered at a calculated dose of 50mg/m2/BSA every 21 days as concomitant therapy to Nimotuzumab, until 6 cycles are completed, exclusion or death occurs, only in patients whose creatinine clearance as defined by the Cockcroft-Gault equation is \>/= 60. The administration form will be intravenously.

DRUG

Gemcitabine

Gemcitabine will be administered at a calculated dose of 800 mg/m2/BSA every 21 days as concomitant therapy to Nimotuzumab, until 6 cycles are completed, exclusion or death occurs, in patients with kidney failure data(Creatinine clearance as defined by the Cockcroft -Gault equation \< 60). The administration form will be intravenously.

PROCEDURE

CT Scan

A CT Scan will be performed in all patients prior to the beginning of treatment to assess any measurable tumor found by this method. The CT Scan will be repeated once the patient completes the induction phase with Nimotuzumab (4 once a week doses), when the patient has completed 3 full cycles of combination therapy with Nimotuzumab (every 2 weeks)and Gemcitabine or Cisplatin (every 21 days)and once more when the patient has completed 6 full cycles of the aforementioned therapy.

Sponsors & Collaborators

• National Institute of Cancerología

  lead OTHER_GOV

Principal Investigators

• Lucely Cetina, MD · Researcher Level D

• Sergio A. Zapata, MD · Instituto Nacional de Cancerologia de Mexico

• Roberto Jimenez, MD · Instituto Nacional de Cancerologia de Mexico

• Tania Crombert, MD · Centro Molecular de La Habana

• Mayra Ramos, MD · Centro Molecular de La Habana

• Ezequiel Fuentes, MD · Pisa® Farmacéutica

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2013-12-31

Completion

2014-03-31

Countries

• Mexico

Study Locations