Clinical trial · Observational
Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Docetaxel is used as a first line anti-cancer drug in the treatment of several cancers, mainly breast- and metastatic castration-resistant prostate carcinoma. Anti-cancer drugs are being dosed based on patients estimated Body Surface Area in order to equalize total drug exposure. Nevertheless, docetaxel treatment is characterized by highly interindividual pharmacokinetic variation leading to toxicity and under-treatment. The investigators will determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlate best to docetaxel exposure (AUC) for both males and females.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Castration-resistant Prostate Carcinoma | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bloodsampling | Other | — | UNRESOLVED |
| Lean body mass | Other | — | UNRESOLVED |
| Total body weight | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- TAC regimen
- description
- Female subject diagnosed with breast carcinoma and will receive docetaxel treatment according to standard hospital protocol
- interventionNames
- Other: Lean body mass
- Other: Total body weight
- Other: bloodsampling
- label
- PRODOC regimen
- description
- male subject diagnosed with metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol
- interventionNames
- Other: Lean body mass
- Other: Total body weight
- Other: bloodsampling
Primary outcomes (1)
- measure
- anthropometric parameters related to exposure
- timeFrame
- within one week prior to first docetaxel dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject is at least 18 * Subject is able and willing to sign the Informed Consent Form prior to screening evaluations * 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) * Subject has a live expectancy of 12 weeks or greater * Absolute neutrophile count (ANC) \> 1.5 x 10E9/L * Platelet count \> 100 x 10E9/L * Serum creatinine ≤ 2 x ULN * Total bilirubin level \< 1.5 x ULN Exclusion Criteria: * Docetaxel treatment within the last year * Moderate or severe liver impairment; \[ALAT and/or ASAT ≥ 1.5 ULN\] and \[AF ≥ 2.5 ULN\] * Current therapy with any drug, dietary supplements, or other compounds, or have been used in the last 2 weeks prior to the first docetaxel administration, known to inhibit or induce CYP3A4. * Inability to understand the nature and extent of the study and the procedures required
References
Publications (0)
Data not yet available