Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity

NCT01621425 | Completed

• 1 other identifier: UMCN-AKF 11.01
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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. 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

Breast Cancer; Metastatic Castration-resistant Prostate Carcinoma

Keywords

breast cancer; prostate carcinoma; docetaxel; lean body mass; Body Surface Area; body weight; dexascan

Outcome Measures

Primary Outcomes (1)

• anthropometric parameters related to exposure

  To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC) for both males and females

  within one week prior to first docetaxel dose

Secondary Outcomes (2)

• relation between docetaxel toxicity and dose/LBM

  1 cycle (21 days)

• determine the best method to measure lean body mass

  within one week prior to first docetaxel dose

Study Arms (2)

TAC regimen

Female subject diagnosed with breast carcinoma and will receive docetaxel treatment according to standard hospital protocol

Other: Lean body mass; Other: Total body weight; Other: bloodsampling

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; Other: Total body weight; Other: bloodsampling

Interventions

Lean body mass OTHER

Lean Body mass (DEXA scan and Bioelectrical Impedance Assessments) within one week prior to the first docetaxel dose

PRODOC regimen; TAC regimen

Total body weight OTHER

Total Body weight (TBW) (scale) within one week prior to the first docetaxel dose

PRODOC regimen; TAC regimen

bloodsampling OTHER

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; TAC regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (2)

Deventer Hospital

Deventer, Netherlands

Location

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for docetaxel concentration measurement (n=4)

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Body Weight

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rien Hoge, PharmD

  Deventer Ziekenhuis

  PRINCIPAL INVESTIGATOR

• Frank Jansman, PharmD, PhD

  Deventer Ziekenhuis

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: June 18, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

NL (2)