Determination of Carboplatin's Optimal Plasmatic Exposure

NCT ID: NCT00145028

Last Updated: 2009-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2009-02-28

Brief Summary

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

Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Carboplatin

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Claudius Regaud

OTHER

Sponsor Role lead

Responsible Party

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Institut Claudius Regaud

Principal Investigators

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Laurence GLADIEFF, Doctor

Role: PRINCIPAL_INVESTIGATOR

Institut Claudius Regaud

Locations

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Centre Paul Papin

Angers, , France

Site Status

Institut Bergonié

Bordeaux, , France

Site Status

Clinique Pasteur

Évreux, , France

Site Status

CHU A. Michallon

Grenoble, , France

Site Status

Centre Oscar Lambert

Lille, , France

Site Status

CHU de la Timone

Marseille, , France

Site Status

Centre Val d'Aurelle

Montpellier, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

CHU de Nîmes

Nîmes, , France

Site Status

Hopital Européen Georges Pompidou

Paris, , France

Site Status

Clinique Mathilde

Rouen, , France

Site Status

Centre René Gauducheau

Saint Herblain (Nantes), , France

Site Status

CHU de Toulouse Rangueil

Toulouse, , France

Site Status

Institut Claudius Regaud

Toulouse, , France

Site Status

CHRU Bretonneau

Tours, , France

Site Status

Countries

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France

Other Identifiers

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04 GENE 05

Identifier Type: -

Identifier Source: org_study_id

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