Determination of Carboplatin's Optimal Plasmatic Exposure
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Neoplasms
Both
Neoplasms
Trial Information
Determination of Carboplatin's Optimal Plasmatic Exposure
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)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
To determine Carboplatin's optimal exposures (optimal AUCs) and parameters they depend on.
Principal Investigator
Laurence GLADIEFF, Doctor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institut Claudius Regaud
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
04 GENE 05
NCT ID:
NCT00145028
Start Date:
May 2005
Completion Date:
February 2009
Related Keywords:
- Neoplasms
- Neoplasms
- Carboplatin
- optimal exposure
- AUC
- Neoplasms
Name | Location |
|---|
