Exposure and toxicity of docetaxel treatment with patients with breast or metastatic castration-resistant prostate carcinoma. MedDRA version: 16.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Docetaxel Actavis
Product Name: Docetaxel Actavis
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DOCETAXEL
CAS Number: 114977-28-5
Concentration unit: mg/m
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is at least 18 2. Subject is able and willing to sign the Informed Consent Form prior to screen-ing evaluations 3. Subject has been diagnosed with either breast or metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol 4. Subject has an live expectancy of 12 weeks or greater 5. Absolute neutrophile count (ANC) > 1.5 x 109/L 6. Platelet count > 100 x 109/L 7. Serum creatinine = 2 x ULN 8. Total bilirubin level =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Moderate or severe liver impairment; [ALAT and/or ASAT = 1.5 ULN] and [AF = 2.5 ULN] 2. Current therapy with any drug, dietary supplements, or other compounds, or have been used in the last 2 weeks prior to the docetaxel administration, known to inhibit or induce CYP3A4 as mentioned on the list in appendix A. 4. Inability to understand the nature and extent of the study and the procedures required
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC) for both males and females.;Secondary Objective: To determine if occurrence of docetaxel toxicity can be related to dose/Lean body mass. To determine which methods to measure Lean body mass: DEXA, Bioelectrical Impedance As-sessment (BIA) or formula estimates are accurate enough to be used for dosing drugs. ;Primary end point(s): Correlation between Lean Body Mass, total body weight, body surface area and exposure of docetaxel (AUC).;Timepoint(s) of evaluation of this end point: Day one, first administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Correlation between dose/lean body mass and toxicitiy of docetaxel after first administration.;Timepoint(s) of evaluation of this end point: Until the next docetaxel administration or end of trial if earlier. | — |
Countries
Netherlands
Contacts
Public ContactAngela Colbers
Radboud University Nijmegen Medical Centre
Outcome results
None listed