Primary objective:To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC). Secondary objectives:To determine if occurrence of docetaxel toxicity can be related to dose/LBM.To…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For evaluating the primary objective linear regression analysis is performed
between the measures of docetaxel exposure (AUC0-*) and LBM respectively BSA.
Coefficients of determination (R2) of both lines will be statistically
evaluated.
Secondary outcome
For comparing multiple determinants (LBM, BSA, TBW) an linear regressiion
analysis will be performed.
Adverse effect and toxicity events are scored via the CTCAE criteria. All
events are scored between Grade 1 and 4 equally dose delays, dose reductions
and treatment termination. Overall toxicity will be defined as DLT comprising
(any grade 3/4 toxicity, dose delay, reduction or termination) and will be
correlated to the dose docetaxel/ anthropometric parameters (LBM, BSA and TBW).
Background summary
Docetaxel is used as a first line anti-cancer drug in the treatment of several
cancers, mainly breast- and metastatic castration-resistant prostate carcinoma.
Most anti-cancer drugs are being dosed based on patients estimated Body Surface
Area in order to equalize total drug exposure. Nevertheless, docetaxel
treatment is character-ized by highly interindividual pharmacokinetic variation
leading to toxicity and under-treatment.
For some anti cander drugs, including docetaxel, other anthropometric
parameters, such as Lean Body Mass (LBM), have been suggested to be better
than Body Surface Are (BSA) as a determinant for dosing.
Study objective
Primary objective:
To determine which anthropometric parameters, LBM, total body weight (TBW) or
BSA correlates best to docetaxel exposure (AUC).
Secondary objectives:
To determine if occurrence of docetaxel toxicity can be related to dose/LBM.
To determine which methods to measure LBM: DEXA, Bioelectrical Impedance
As-sessments (BIA) or formula estimates are accurate enough for dosing
calculations. to be used for dosing docetaxel.
Study design
Observational, Multicentre, Pilot Study
Study burden and risks
1. The needle used for bloodsampling can cause discomfort or pain near the
puncture site.
2. The risk of the amount of used X-rays at the DEXA scan is negligible. It is
important to be aware of (possible) pregnancy due to possible teratogenicity of
exposure of the unborn child to X-rays.
3. The risk of a treatement with docetaxel will not change. Subjects can
experience side effects of docetaxel.
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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. Female subject diagnosed with breast carcinoma and will receive docetaxel treatment according to standard hospital protocol (TAC regimen) or male subject diagnosed with metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol (PRODOC regimen)
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 < 1.5 x ULN;
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.;
3. Inability to understand the nature and extent of the study and the procedures required;
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-005168-14-NL |
| CCMO | NL38529.091.12 |