Determination of Carboplatin's Optimal Plasmatic Exposure

This study has been completed.
Sponsor:
Information provided by:
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT00145028
First received: September 2, 2005
Last updated: March 17, 2009
Last verified: March 2009
  Purpose

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


Condition Intervention
Neoplasms
Drug: Carboplatin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Determination of Carboplatin's Optimal Plasmatic Exposure

Resource links provided by NLM:


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
Study Completion Date: February 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145028

Locations
France
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
Investigators
Principal Investigator: Laurence GLADIEFF, Doctor Institut Claudius Regaud
  More Information

No publications provided

Responsible Party: Dr Laurence GLADIEFF, Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT00145028     History of Changes
Other Study ID Numbers: 04 GENE 05
Study First Received: September 2, 2005
Last Updated: March 17, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on August 20, 2014