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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00518193
Recruitment Status : Terminated (high rate of medullar aplasia with infectious troubles.)
First Posted : August 20, 2007
Last Update Posted : June 30, 2011
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Brief Summary:

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 or disease Intervention/treatment Phase
Cervix Cancer Drug: ERBITUX Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2007
Actual Primary Completion Date : July 2007
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

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

Intervention Details:
    Drug: ERBITUX
    400 mg/m² 2h injection at week 1, then 250 mg/m² in one hour injection the following weeks

Primary Outcome Measures :
  1. responses rate regarding the RECIST criteria. [ Time Frame: up to progression ]

Secondary Outcome Measures :
  1. Quality of life, free interval, safety. [ Time Frame: up to progression ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00518193

CRLC Val d'Aurelle
Montpellier, France, 34298
Paris, France, 75004
Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame
Paris, France, 75004
Centre Claudius Régaud
Toulouse, France, 31052
Sponsors and Collaborators
Principal Investigator: Pr KURTZ Jean Emmanuel STRASBOURG

Additional Information:
Responsible Party: Frédéric MARMION, ARCAGY-GINECO Identifier: NCT00518193     History of Changes
Other Study ID Numbers: ERBUS
First Posted: August 20, 2007    Key Record Dates
Last Update Posted: June 30, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents