Phase II Study , Association of Cisplatine Topotecan and Cetuximab in Patients Whith Late or in Progress Epithelial Cancer of the Cervix (ERBUS)

June 29, 2011 updated by: ARCAGY/ GINECO GROUP

The efficacy of chimiotherapy in cervix epithelial cancer is low even with the association cisplatine - topotecan .

News thérapeutics are needed in the goal of increase the survival and quality of life in patients with cervix cancer.

Cetuximab has shown the potentialisation on the efficacy of cisplatine and irinotecan.

Cisplatine and topotecan have shown an efficacy in cervix cancer. Cetuximab is well tolerate. Many clinical trials shown the faisability of the association of cetuximab and cisplatine in cancer.

Many clinical trials have shown the faisability of association of cetuximab and irinotecan in colorectals metastatiques cancers .

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34298
        • CRLC Val d'Aurelle
      • Paris, France, 75004
        • Hôpital Hotel Dieu
      • Paris, France, 75004
        • Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame
      • Toulouse, France, 31052
        • Centre Claudius Régaud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • More than 18 years old.
  • Epidermoïde carcinoma or adenocarcinoma of the cervix, hystologic proved
  • Patientes in a late stage or with progresive desease.
  • One mesurable lesion in irradiated zone.
  • Patient who have already treated radio-chimiothérapy with platine should have a 6 month free interval.
  • Index status of ECOG (" Eastern Cooperative Oncology Group ")less than 2.
  • Good biologicals and hematologicals fonctions:
  • Neutrophiles noless than 1,5.109/L.
  • Platelets nolss than 100.109/L.
  • Total bilirubin no more than 1,5 time the normal superior range.
  • Transaminases no mote than 3 x Time NSR
  • Creatinine clairance Cockroft) more than 50 mL/min .
  • Inform consent signed.

Exclusion Criteria:

  • Previous cytotoxic traitement exept radio-chaemiotherapy of the pelvis cerebrals metastasis.
  • Other cancer in the last 5 years exept treated BCC.
  • Dermatologic desease.
  • Crohn desease or Hemorragic rectal-Colitis.
  • Neuropathy.
  • Psychologic disorder.
  • Social troubles.
  • Pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
responses rate regarding the RECIST criteria.
Time Frame: up to progression
up to progression

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life, free interval, safety.
Time Frame: up to progression
up to progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCAGY/ GINECO GROUP

Investigators

  • Principal Investigator: Pr KURTZ Jean Emmanuel, Strasbourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

August 14, 2007

First Submitted That Met QC Criteria

August 17, 2007

First Posted (Estimate)

August 20, 2007

Study Record Updates

Last Update Posted (Estimate)

June 30, 2011

Last Update Submitted That Met QC Criteria

June 29, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERBUS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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