Determination of Carboplatin's Optimal Plasmatic Exposure

Neoplasms Clinical Trial

Official title:

Determination of Carboplatin's Optimal Plasmatic Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00145028
• Other study ID #: 04 GENE 05
• Status: Completed
• Phase: N/A
• First received: September 2, 2005
• Last updated: March 17, 2009
• Start date: May 2005
• Est. completion date: February 2009

Study information

• Verified date: March 2009
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Carboplatin

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine Carboplatin's optimal exposures (optimal AUCs) and parameters they depend on.
Secondary	To assign a standardization method for Carboplatin doses's calculation in chemotherapy's protocol including this drug.