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

Sponsor
ARCAGY/ GINECO GROUP (Other)
Overall Status
Terminated
CT.gov ID
NCT00518193
Collaborator
(none)
44
Enrollment
4
Locations
17.1
Duration (Months)
11
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Apr 1, 2007
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Sep 1, 2008

Outcome Measures

Primary Outcome Measures

  1. responses rate regarding the RECIST criteria. [up to progression]

Secondary Outcome Measures

  1. Quality of life, free interval, safety. [up to progression]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CRLC Val d'Aurelle Montpellier France 34298
2 Hôpital HOTEL DIEU Paris France 75004
3 Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame Paris France 75004
4 Centre Claudius Régaud Toulouse France 31052

Sponsors and Collaborators

  • ARCAGY/ GINECO GROUP

Investigators

  • Principal Investigator: Pr KURTZ Jean Emmanuel, STRASBOURG

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00518193
Other Study ID Numbers:
  • ERBUS
First Posted:
Aug 20, 2007
Last Update Posted:
Jun 30, 2011
Last Verified:
Jun 1, 2011
Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Cetuximab

Study Results

No Results Posted as of Jun 30, 2011