Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity (LEANDOC)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Metastatic Castration-resistant Prostate Carcinoma |
Other: Lean body mass Other: Total body weight Other: bloodsampling |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity |
- anthropometric parameters related to exposure [ Time Frame: within one week prior to first docetaxel dose ] [ Designated as safety issue: No ]To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC) for both males and females
- relation between docetaxel toxicity and dose/LBM [ Time Frame: 1 cycle (21 days) ] [ Designated as safety issue: Yes ]can docetaxel toxicity be related to dose/LBM? docetaxel toxicity is defined as: number of rates of grade 3/4 toxicity, dose delay, dose reduction, treatment termination and combinations of all four as Dose-Limiting Toxicity (DLT)
- determine the best method to measure lean body mass [ Time Frame: within one week prior to first docetaxel dose ] [ Designated as safety issue: No ]To determine which methods to measure LBM: Bioelectrical Impedance As-sessments (BIA) or formula estimates are accurate enough for dosing calculations to be used for dosing docetaxel. These methods will be compared to the LBM derived from the DEXA scan as the general accepted, accurate and validated method for determining LBM.
Biospecimen Retention: Samples Without DNA
Blood samples for docetaxel concentration measurement (n=4)
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
TAC regimen
Female subject diagnosed with breast carcinoma and will receive docetaxel treatment according to standard hospital protocol
|
Other: Lean body mass
Lean Body mass (DEXA scan and Bioelectrical Impedance Assessments) within one week prior to the first docetaxel dose
Other: Total body weight
Total Body weight (TBW) (scale) within one week prior to the first docetaxel dose
Other: bloodsampling
Blood samples will be taken during the first docetaxel administration of the first cycle, just before docetaxel infusion (t=0 min.), 30 min after start of infusion (t=30 min.), just prior to end of infusion (t=55 min.) and between 3 to 6 hours post start infusion following a limited sampling model
|
|
PRODOC regimen
male subject diagnosed with metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol
|
Other: Lean body mass
Lean Body mass (DEXA scan and Bioelectrical Impedance Assessments) within one week prior to the first docetaxel dose
Other: Total body weight
Total Body weight (TBW) (scale) within one week prior to the first docetaxel dose
Other: bloodsampling
Blood samples will be taken during the first docetaxel administration of the first cycle, just before docetaxel infusion (t=0 min.), 30 min after start of infusion (t=30 min.), just prior to end of infusion (t=55 min.) and between 3 to 6 hours post start infusion following a limited sampling model
|
Detailed Description:
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.
For most anti-cancer drugs, including docetaxel, other anthropometric parameters, such as Lean Body Mass (LBM), have been suggested to be superior to Body Surface Are (BSA) as a determinant for dosing but this has not been implemented in clinical practice.
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.
The investigators will determine if occurrence of docetaxel toxicity can be related to dose/LBM.
The investigators will determine which methods to measure LBM: DEXA, Bioelectrical Impedance Assessments (BIA) or formula estimates are accurate enough for dosing calculations to be used for dosing docetaxel.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
20 female subjects who are diagnosed with breast and 20 male subjects with metas-tatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol (TAC or PRODOC regimens)
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
Contacts and Locations| Contact: David Burger, Prof | +31 24 3616405 | d.burger@akf.umcn.nl |
| Contact: Angela Colbers, MSc | +31 24 3616405 | a.colbers@akf.umcn.nl |
| Netherlands | |
| Deventer Hospital | Recruiting |
| Deventer, Netherlands | |
| Contact: Rien Hoge, PharmD | |
| Principal Investigator: Frank Jansman, PharmD, PhD | |
| Radboud University Nijmegen Medical Centre | Recruiting |
| Nijmegen, Netherlands | |
| Contact: David Burger, Prof | |
| Principal Investigator: Carla v Herpen, MD | |
| Principal Investigator: | Rien Hoge, PharmD | Deventer Ziekenhuis |
| Study Chair: | Frank Jansman, PharmD, PhD | Deventer Ziekenhuis |
More Information
No publications provided
| Responsible Party: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT01621425 History of Changes |
| Other Study ID Numbers: | UMCN-AKF 11.01 |
| Study First Received: | May 25, 2012 |
| Last Updated: | November 12, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
breast cancer prostate carcinoma docetaxel lean body mass |
Body Surface Area body weight dexascan |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma Prostatic Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013