Pharmacokinetics and Pharmacogenetics-based Adaptive Dosing of 5-fu (5-Fluorouracile) in Head & Neck Cancer Patient Undergoing Docetaxel, Cisplatin, 5-Fluorouracile (=TPF) Therapy (5-FU)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02484677|
Recruitment Status : Unknown
Verified June 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was: Recruiting
First Posted : June 30, 2015
Last Update Posted : June 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Patients With Head and Neck Cancer (ORL)||Drug: Cisplatin Drug: Docetaxel Drug: 5-Fluorouracile||Phase 4|
Crop the plasma exposure of 5-FU (5-Fluorouracile) around a predefined target area under the curve 30 (AUC30) in patients with head and neck cancer treated with Docetaxel, Cisplatin, 5-Fluorouracile (=TPF) protocols and correlate adaptive Bayesian procedure to tolerability.
- Develop a population die from a group of 20 patients for which a pharmacokinetic study will be carried out
- Evaluate obtaining effective concentration of 5-FU in the context of a Docetaxel, Cisplatin, 5-Fluorouracile (=TPF) protocol adapted by the Bayesian procedure.
- Compare recommendations in terms of dosage adjustment of Bayesian approach with the recommendations of a simplified graphical approach.
- Test the measure of Dihydro Pyrimidine Dehydrogenase (DPD) activity Dihydrouracil/Uracile (UH2 / U ratio) as a co-variable adjustment of 5-Fluorouracile (5-FU) regimens in Pharmacogenomics/Pharmacokinetic (PGx / PK) model.
- Evaluate a prototype of urinary dipsticks for the early detection of toxicity from the assay as a marker of Dihydro Pyrimidine Dehydrogenase (DPD) activity.
- Assess the cost-benefit of dosage targeting, in terms of reduction resulting costs to the management of chemotherapy-induced toxicities.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics and Pharmacogenetics-based Adaptive Dosing of 5-fu (5-Fluorouracile) in Head & Neck Cancer Patient Undergoing Docetaxel, Cisplatin, 5-Fluorouracile (=TPF) Therapy|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2017|
Experimental: Head and neck cancer patient
Association of Docetaxel, Cisplatin, 5-Fluorouracile for pharmacokinetic evaluation
Antineoplastic cytostatic. Blood sampling for pharmacokinetic evaluation
Taxanes. Blood sampling for pharmacokinetic evaluation
Antineoplastic and immunomodulating agents. Blood sampling for pharmacokinetic evaluation
- Determination of 5-FU (5-Fluorouracile) [ Time Frame: 24 months ]Concentration of 5-FU in nanograms per milliliter. Circulating 5-FU will be quantified by immunoassay.
- Toxicities [ Time Frame: 24 months ]will be graded according to Common toxicity Criteria (CTC) 2.0 standards.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484677
|Contact: Sébastien SALAS, Professorfirstname.lastname@example.org|
|Contact: Urielle DESALBRES, Directoremail@example.com|
|Assistance Publique Hôpitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: Urielle DESALBRES, Director|
|Principal Investigator: Sebastien SALAS, Professor|
|Study Director:||Urielle DESALBRES, Director||Assistance Publique Hôpitaux de Marseille|