ean Body Mass as a determinant of docetaxel pharmacokinetics and toxicity (LEANDOC)

Phase 4

Completed

Conditions: Breast cancer
Mamma carcinoma
Prostate cancer
Prostate carcinoma
10006291
10036958

Registration Number: NL-OMON39781

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

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;

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For evaluating the primary objective linear regression analysis is performed<br /><br>between the measures of docetaxel exposure (AUC0-*) and LBM respectively BSA.<br /><br>Coefficients of determination (R2) of both lines will be statistically<br /><br>evaluated.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>For comparing multiple determinants (LBM, BSA, TBW) an linear regressiion<br /><br>analysis will be performed.<br /><br><br /><br>Adverse effect and toxicity events are scored via the CTCAE criteria. All<br /><br>events are scored between Grade 1 and 4 equally dose delays, dose reductions<br /><br>and treatment termination. Overall toxicity will be defined as DLT comprising<br /><br>(any grade 3/4 toxicity, dose delay, reduction or termination) and will be<br /><br>correlated to the dose docetaxel/ anthropometric parameters (LBM, BSA and TBW). </p><br>