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Determination of Carboplatin's Optimal Plasmatic Exposure
This study is currently recruiting participants.
Verified by Institut Claudius Regaud, November 2006
Sponsored by: Institut Claudius Regaud
Information provided by: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT00145028
  Purpose

To determine Carboplatin's optimal exposures(optimal AUCs)and parameters they depend on.


Condition Intervention
Neoplasms
 Drug: Carboplatin

MedlinePlus related topics: Cancer
Drug Information available for: Carboplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title: Determination of Carboplatin's Optimal Plasmatic Exposure

Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • To determine Carboplatin's optimal exposures (optimal AUCs) and parameters they depend on.

Secondary Outcome Measures:
  • To assign a standardization method for Carboplatin doses's calculation in chemotherapy's protocol including this drug.

Estimated Enrollment: 400
Study Start Date: May 2005
Estimated Study Completion Date: December 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00145028

Contacts
Contact: Etienne CHATELUT, Professor +33 5.61.42.42.71 Chatelut.Etienne@claudiusregaud.fr

Locations
France
Institut Claudius Regaud Recruiting
Toulouse, France
Contact: Laurence GLADIEFF, Doctor     +33 5.61.42.41.36     Gladieff.Laurence@claudiusregaud.fr    
Sub-Investigator: Florence Dalenc, Doctor            
Sub-Investigator: Loic Mourey, Doctor            
Sub-Investigator: Jean Pierre Delord, Doctor            
Sub-Investigator: Nathalie Caunes, Doctor            
Centre Paul Papin Recruiting
Angers, France
Contact: Erick Gamelin, Pr            
CHU A. Michallon Recruiting
Grenoble, France
Contact: Mireille Mousseau, Pr            
CHU de la Timone Recruiting
Marseille, France
Contact: Cedric Mercier, Dr            
Centre Val d'Aurelle Recruiting
Montpellier, France
Contact: Michel Fabbro, Dr            
Centre René Gauducheau Recruiting
Saint Herblain (Nantes), France
Contact: Mario Campone, Dr            
Centre Antoine Lacassagne Recruiting
Nice, France
Contact: Remy Largillier, Dr            
Clinique Mathilde Recruiting
ROUEN, France
Contact: Nicolas Albin, Dr            
Hopital Européen Georges Pompidou Recruiting
Paris, France
Contact: Catherine Durdux, Dr            
CHU de Toulouse Rangueil Recruiting
Toulouse, France
Contact: Julien Mazières, Dr            
CHRU Bretonneau Recruiting
Tours, France
Contact: Philippe Bougnoux, Dr            
Centre Oscar Lambert Recruiting
Lille, France
Contact: Annick Chevalier, Dr            
Institut Bergonié Recruiting
Bordeaux, France
Contact: Anne Floquet, Dr            
Clinique Pasteur Recruiting
Evreux, France
Contact: Nicolas Albin, Dr            
CHU de Nîmes Recruiting
Nîmes, France
Contact: Bruno Richard, Dr            
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
Principal Investigator: Laurence GLADIEFF, Doctor Institut Claudius Regaud
  More Information

Study ID Numbers: 04 GENE 05
Study First Received: September 2, 2005
Last Updated: April 5, 2007
ClinicalTrials.gov Identifier: NCT00145028  
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Claudius Regaud:
Neoplasms
Carboplatin
optimal exposure
AUC

Study placed in the following topic categories:
Carboplatin

Additional relevant MeSH terms:
Neoplasms
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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