Determination of Carboplatin's Optimal Plasmatic Exposure
Information source: Institut Claudius Regaud
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neoplasms
Intervention: Carboplatin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Institut Claudius Regaud Official(s) and/or principal investigator(s):
Laurence GLADIEFF, Doctor, Principal Investigator, Affiliation: Institut Claudius Regaud
Overall contact:
Etienne CHATELUT, Professor, Phone: +33 5.61.42.42.71, Email: Chatelut.Etienne@claudiusregaud.fr
Summary
To determine Carboplatin's optimal exposures(optimal AUCs)and parameters they depend on.
Clinical Details
Official title: Determination of Carboplatin's Optimal Plasmatic Exposure
Study design: Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: To determine Carboplatin's optimal exposures (optimal AUCs) and parameters they depend on.
Secondary outcome: To assign a standardization method for Carboplatin doses's calculation in chemotherapy's protocol including this drug.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Etienne CHATELUT, Professor, Phone: +33 5.61.42.42.71, Email: Chatelut.Etienne@claudiusregaud.fr
Institut Claudius Regaud, Toulouse, France; Recruiting
Laurence GLADIEFF, Doctor, Phone: +33 5.61.42.41.36, Email: Gladieff.Laurence@claudiusregaud.fr
Florence Dalenc, Doctor, Sub-Investigator
Loic Mourey, Doctor, Sub-Investigator
Jean Pierre Delord, Doctor, Sub-Investigator
Nathalie Caunes, Doctor, Sub-Investigator
Centre Paul Papin, Angers, France; Recruiting
Erick Gamelin, Pr
CHU A. Michallon, Grenoble, France; Recruiting
Mireille Mousseau, Pr
CHU de la Timone, Marseille, France; Recruiting
Cedric Mercier, Dr
Centre Val d'Aurelle, Montpellier, France; Recruiting
Michel Fabbro, Dr
Centre René Gauducheau, Saint Herblain (Nantes), France; Recruiting
Mario Campone, Dr
Centre Antoine Lacassagne, Nice, France; Recruiting
Remy Largillier, Dr
CHU de Nîmes, Nîmes, France; Recruiting
Bruno Richard, Dr
Hopital Européen Georges Pompidou, Paris, France; Recruiting
Catherine Durdux, Dr
CHU de Toulouse Rangueil, Toulouse, France; Recruiting
Julien Mazières, Dr
CHRU Bretonneau, Tours, France; Recruiting
Philippe Bougnoux, Dr
Centre Oscar Lambert, Lille, France; Recruiting
Annick Chevalier, Dr
Institut Bergonié, Bordeaux, France; Recruiting
Anne Floquet, Dr
Clinique Pasteur, Evreux, France; Recruiting
Nicolas Albin, Dr
Clinique Mathilde, ROUEN, France; Recruiting
Nicolas Albin, Dr
Additional Information
Starting date: May 2005
Ending date: December 2008
Last updated: April 5, 2007
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