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

Phase 2

Terminated

• Conditions: Cervix Cancer

• Registration Number: NCT00518193
• Lead Sponsor: ARCAGY/ GINECO GROUP

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2007-07
• Study First Submitted: 2007-08-14
• Study First Submitted QC: 2007-08-17
• Study First Posted: 2007-08-20
• Study Completion: 2008-09
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-29
• Last Update Posted: 2011-06-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
responses rate regarding the RECIST criteria.	up to progression

Secondary Outcome Measures

Name	Time	Method
Quality of life, free interval, safety.	up to progression

Trial Locations

Locations (4)

Hôpital HOTEL DIEU; 🇫🇷 Paris, France

CRLC Val d'Aurelle; 🇫🇷 Montpellier, France

Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame; 🇫🇷 Paris, France

Centre Claudius Régaud; 🇫🇷 Toulouse, France