Determination of Carboplatin's Optimal Plasmatic Exposure
1 other identifier
interventional
400
1 country
15
Brief Summary
To determine Carboplatin's optimal exposures(optimal AUCs)and parameters they depend on.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2005
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedMarch 18, 2009
March 1, 2009
2.6 years
September 2, 2005
March 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine Carboplatin's optimal exposures (optimal AUCs) and parameters they depend on.
Secondary Outcomes (1)
To assign a standardization method for Carboplatin doses's calculation in chemotherapy's protocol including this drug.
Interventions
Eligibility Criteria
You may qualify if:
- Carcinoma histologically proved and which must be treated by Carboplatin, excepted weekly administered Carboplatin treatments
- Age \> 18 years
- Neutrophils \> 1500/mm3, blood-platelets \> 100000/mm3
- Patient with intravenous administration route for chemotherapy independent of the one used for blood samples ( for Investigators centers achieving pharmacokinetic examination)
- Well-informed written consent, signed by the patient
You may not qualify if:
- Carboplatin treatment's contra-indication
- Patient with clinically detectable cerebral metastasis
- Pregnant or nursing women
- Patient under guardianship or trusteeship
- Patient whose venous status don't permit a peripheral intravenous administration route's placing (for Investigators centers achieving pharmacokinetic examination)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Centre Paul Papin
Angers, France
Institut Bergonié
Bordeaux, France
Clinique Pasteur
Évreux, France
CHU A. Michallon
Grenoble, France
Centre Oscar Lambert
Lille, France
CHU de la Timone
Marseille, France
Centre Val d'Aurelle
Montpellier, France
Centre Antoine Lacassagne
Nice, France
CHU de Nîmes
Nîmes, France
Hopital Européen Georges Pompidou
Paris, France
Clinique Mathilde
Rouen, France
Centre René Gauducheau
Saint Herblain (Nantes), France
CHU de Toulouse Rangueil
Toulouse, France
Institut Claudius Regaud
Toulouse, France
CHRU Bretonneau
Tours, France
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurence GLADIEFF, Doctor
Institut Claudius Regaud
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 5, 2005
Study Start
May 1, 2005
Primary Completion
December 1, 2007
Study Completion
February 1, 2009
Last Updated
March 18, 2009
Record last verified: 2009-03