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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00518193

Acronym

ERBUS

Enrollment

Registered

2007-08-20

Start date

2007-04-30

Completion date

2008-09-30

Last updated

2011-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervix Cancer

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 .

Interventions

DRUGERBITUX

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
responses rate regarding the RECIST criteria.	up to progression

Secondary

Measure	Time frame
Quality of life, free interval, safety.	up to progression

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026