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

This study has been terminated.
(high rate of medullar aplasia with infectious troubles.)
Sponsor:
Information provided by:
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT00518193
First received: August 14, 2007
Last updated: June 29, 2011
Last verified: June 2011
History of Changes
  Purpose

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 .


Condition Intervention Phase
Cervix Cancer
 Drug: ERBITUX
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Cetuximab
U.S. FDA Resources

Further study details as provided by ARCAGY/ GINECO GROUP:

Primary Outcome Measures:
  • responses rate regarding the RECIST criteria. [ Time Frame: up to progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life, free interval, safety. [ Time Frame: up to progression ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: April 2007
Study Completion Date: September 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ERBITUX
    400 mg/m² 2h injection at week 1, then 250 mg/m² in one hour injection the following weeks
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518193

Locations
France
CRLC Val d'Aurelle
Montpellier, France, 34298
Hôpital HOTEL DIEU
Paris, France, 75004
Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame
Paris, France, 75004
Centre Claudius Régaud
Toulouse, France, 31052
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Investigators
Principal Investigator: Pr KURTZ Jean Emmanuel STRASBOURG
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Frédéric MARMION, ARCAGY-GINECO
ClinicalTrials.gov Identifier: NCT00518193     History of Changes
Other Study ID Numbers: ERBUS
Study First Received: August 14, 2007
Last Updated: June 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
 Uterine Diseases
Genital Diseases, Female
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013