Determination of Carboplatin's Optimal Plasmatic Exposure

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: NCT00145028
• Lead Sponsor: Institut Claudius Regaud

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Primary Completion: 2007-12
• Study Completion: 2009-02
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-17
• Last Update Posted: 2009-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To assign a standardization method for Carboplatin doses's calculation in chemotherapy's protocol including this drug.

Trial Locations

Locations (15)

CHU A. Michallon; 🇫🇷 Grenoble, France

Centre Oscar Lambert; 🇫🇷 Lille, France

Centre Paul Papin; 🇫🇷 Angers, France

Clinique Pasteur; 🇫🇷 Evreux, France

CHU de la Timone; 🇫🇷 Marseille, France

Centre Val d'Aurelle; 🇫🇷 Montpellier, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Centre René Gauducheau; 🇫🇷 Saint Herblain (Nantes), France

CHU de Toulouse Rangueil; 🇫🇷 Toulouse, France

Hopital Européen Georges Pompidou; 🇫🇷 Paris, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

CHU de Nîmes; 🇫🇷 Nîmes, France

Clinique Mathilde; 🇫🇷 Rouen, France

CHRU Bretonneau; 🇫🇷 Tours, France