Back to resultsPhase II Study , Association of Cisplatine Topotecan and Cetuximab in Patients Whith Late or in Progress Epithelial Cancer of the Cervix (ERBUS)
Primary Purpose
Cervix Cancer
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
ERBITUX
Sponsored by
About this trial
This is an interventional treatment trial for Cervix Cancer
Eligibility Criteria
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.
Sites / Locations
- CRLC Val d'Aurelle
- Hôpital HOTEL DIEU
- Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame
- Centre Claudius Régaud
Outcomes
Primary Outcome Measures
responses rate regarding the RECIST criteria.
Secondary Outcome Measures
Quality of life, free interval, safety.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00518193
Brief Title
Phase II Study , Association of Cisplatine Topotecan and Cetuximab in Patients Whith Late or in Progress Epithelial Cancer of the Cervix
Acronym
ERBUS
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Why Stopped
high rate of medullar aplasia with infectious troubles.
Study Start Date
April 2007 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
ARCAGY/ GINECO GROUP
4. Oversight
Data Monitoring Committee
Yes
5. 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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ERBITUX
Intervention Description
400 mg/m² 2h injection at week 1, then 250 mg/m² in one hour injection the following weeks
Primary Outcome Measure Information:
Title
responses rate regarding the RECIST criteria.
Time Frame
up to progression
Secondary Outcome Measure Information:
Title
Quality of life, free interval, safety.
Time Frame
up to progression
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pr KURTZ Jean Emmanuel
Organizational Affiliation
STRASBOURG
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRLC Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Hôpital HOTEL DIEU
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
Centre Claudius Régaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
12. IPD Sharing Statement
Links:
URL
http://www.arcagy.org
Description
Related Info
Learn more about this trial
Phase II Study , Association of Cisplatine Topotecan and Cetuximab in Patients Whith Late or in Progress Epithelial Cancer of the Cervix
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