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Study of Adding Cetuximab to Chemotherapy for the Treatment of Advanced and/or Recurrent Cervical Cancer

NCT00997009 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2023-11-14

No results posted yet for this study

Summary

This study aims to assess the activity of a combination of cetuximab (weekly) with carboplatin + paclitaxel (every three weeks) comparing it to chemotherapy alone in terms of event-free survival (EFS).

Conditions

Interventions

DRUG

paclitaxel

175 mg/m2 IV day 1, every 21 days

DRUG

carboplatin

AUC 5 IV day 1 every 21 days

DRUG

cetuximab

400 mg/m2 IV, one week before starting carboplatin and paclitaxel; then 250 mg/m2 IV day 1, weekly

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Sandro Pignata, M.D., Ph.D. · National Cancer Institute, Naples

  • Francesco Perrone, M.D., Ph.D. · National Cancer Institute, Naples

  • Alessandro Morabito, M.D., · National Cancer Institute, Naples

  • Ciro Gallo, M.D., Ph.D. · University of Campania Luigi Vanvitelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

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 NCT00997009 on ClinicalTrials.gov