Study Stopped
high rate of medullar aplasia with infectious troubles.
Phase II Study , Association of Cisplatine Topotecan and Cetuximab in Patients Whith Late or in Progress Epithelial Cancer of the Cervix
ERBUS
1 other identifier
interventional
44
1 country
4
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2007
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 14, 2007
CompletedFirst Posted
Study publicly available on registry
August 20, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedJune 30, 2011
June 1, 2011
3 months
August 14, 2007
June 29, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
responses rate regarding the RECIST criteria.
up to progression
Secondary Outcomes (1)
Quality of life, free interval, safety.
up to progression
Interventions
400 mg/m² 2h injection at week 1, then 250 mg/m² in one hour injection the following weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CRLC Val d'Aurelle
Montpellier, 34298, France
Hôpital HOTEL DIEU
Paris, 75004, France
Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame
Paris, 75004, France
Centre Claudius Régaud
Toulouse, 31052, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pr KURTZ Jean Emmanuel
STRASBOURG
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 14, 2007
First Posted
August 20, 2007
Study Start
April 1, 2007
Primary Completion
July 1, 2007
Study Completion
September 1, 2008
Last Updated
June 30, 2011
Record last verified: 2011-06