Determination of Carboplatin's Optimal Plasmatic Exposure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00145028
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : March 18, 2009
Information provided by:
Institut Claudius Regaud

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

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Carboplatin Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Determination of Carboplatin's Optimal Plasmatic Exposure
Study Start Date : May 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Carboplatin
U.S. FDA Resources

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00145028

Centre Paul Papin
Angers, France
Institut Bergonié
Bordeaux, France
Clinique Pasteur
Evreux, 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
Sponsors and Collaborators
Institut Claudius Regaud
Principal Investigator: Laurence GLADIEFF, Doctor Institut Claudius Regaud

Responsible Party: Dr Laurence GLADIEFF, Institut Claudius Regaud Identifier: NCT00145028     History of Changes
Other Study ID Numbers: 04 GENE 05
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: March 18, 2009
Last Verified: March 2009

Keywords provided by Institut Claudius Regaud:
optimal exposure

Additional relevant MeSH terms:
Antineoplastic Agents