NCT02095119

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

Phase I-II Study of Palliative Treatment With Nimotuzumab as a Second, Third Line or More of Treatment for Advanced or Metastatic Cervical Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: National Institute of Cancerología · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2008-07-01
• Primary completion: 2013-12-01
• Completion: 2014-03-01
• First posted: 2014-03-24
• Last updated: 2015-04-14

Locations

1 site across 1 country: Mexico