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

Cervix Cancer Clinical Trial

— ERBUS  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00518193
• Other study ID #: ERBUS
• Status: Terminated
• Phase: Phase 2
• First received: August 14, 2007
• Last updated: June 29, 2011
• Start date: April 2007
• Est. completion date: September 2008

Study information

• Verified date: June 2011
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: September 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cervix Cancer
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	CRLC Val d'Aurelle	Montpellier
France	Hôpital HOTEL DIEU	Paris
France	Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame	Paris
France	Centre Claudius Régaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	responses rate regarding the RECIST criteria.		up to progression	No
Secondary	Quality of life, free interval, safety.		up to progression	Yes

External Links

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