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Combination of Nimotuzumab Cisplatin-Vinorelbine in First Line Chemotherapy in Recurring-Persistent Cervical Carcinoma

NCT02083211 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2015-04-14

No results posted yet for this study

Summary

This study evauates the global survival of patients following administration of mAb Nimotuzumab hR3 + chemotherapy in the treatment of cervical cancer in first line therapy, after relapsing from chemo-radiotherapy.

It is a Phase III, multi-centric, randomized, double blind study; 168 patients will be assigned to Nimotuzumab + Cisplatin/Vinorelbine or placebo + Cisplatin/Vinorelbine. After progression, a second line chemotherapy based on carboplatino/taxol will be administered in both groups. Concomitant administration of Nimotuzumab will be continued every 14 days until limiting toxicity or ECOCG \>3.

Tumor markers such as Kras, p53, KI67, and EGFR will be identified. Cardiac toxicity will be evaluated using MRI.

Conditions

  • Cervical Cancer Recurrent or Persistent
  • Palliative Treatment
  • Monoclonal Antibody in Cervical Cancer Treatment

Interventions

DRUG

mAb Nimotuzumab

This group will receive a dose of 200 mg mAb hR3 (weekly over 18 weeks) plus chemotherapy (6 cycles every 21 days of Cisplatin (CDDP) 50 mg/m2 on day 1/, Vinorelbine 30 mg/m2 on day 1 and day 8)

DEVICE

Placebo

This group will receive a placebo in addition to chemotherapy in a similar regimen. Once the chemotherapy is completed a maintenance dose will be administered with 200 mg/dose of mAb hR3 every 14 days until progression.

Sponsors & Collaborators

  • Pisa S.A de C.V

    collaborator UNKNOWN

  • National Heart Institute, Mexico

    collaborator OTHER_GOV

  • National Institute of Cancerología

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-05-31
Completion
2014-06-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02083211 on ClinicalTrials.gov