Determination of Carboplatin's Optimal Plasmatic Exposure

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00145028

Enrollment

400

Registered

2005-09-05

Start date

2005-05-31

Completion date

2009-02-28

Last updated

2009-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Neoplasms, Carboplatin, optimal exposure, AUC

Brief summary

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

Interventions

DRUGCarboplatin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
To assign a standardization method for Carboplatin doses's calculation in chemotherapy's protocol including this drug.	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026