Phase II Study , Association of Cisplatine Topotecan and Cetuximab in Patients Whith Late or in Progress Epithelial Cancer of the Cervix
NCT ID: NCT00518193
Last Updated: 2011-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
44 participants
INTERVENTIONAL
2007-04-30
2008-09-30
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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ERBITUX
400 mg/m² 2h injection at week 1, then 250 mg/m² in one hour injection the following weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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ARCAGY/ GINECO GROUP
OTHER
Responsible Party
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ARCAGY-GINECO
Principal Investigators
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Pr KURTZ Jean Emmanuel
Role: PRINCIPAL_INVESTIGATOR
STRASBOURG
Locations
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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, , France
Countries
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Related Links
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Related Info
Other Identifiers
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ERBUS
Identifier Type: -
Identifier Source: org_study_id