Breast CancerLEANDOCNCT01621425
Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity
An observational study of Breast Cancer and Metastatic Castration-resistant Prostate Carcinoma, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Metastatic Castration-resistant Prostate Carcinoma
- What is being tested?
- Lean body mass, Total body weight and bloodsampling
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jun 2012to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Deventer Hospital
Deventer
Radboud University Nijmegen Medical Centre
Nijmegen
About this study
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.
Read the 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.
- Being tested
- Lean body mass, Total body weight, bloodsampling
- Keywords
- breast cancer, prostate carcinoma, docetaxel, lean body mass, Body Surface Area, body weight, dexascan
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lean body massOther
Lean Body mass (DEXA scan and Bioelectrical Impedance Assessments) within one week prior to the first docetaxel dose
Total body weightOther
Total Body weight (TBW) (scale) within one week prior to the first docetaxel dose
bloodsamplingOther
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
| Study group | Role | What they receive |
|---|---|---|
| TAC regimen | Female subject diagnosed with breast carcinoma and will receive docetaxel treatment according to standard hospital protocol Receives: 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 Receives: Other: Lean body mass; Other: Total body weight; Other: bloodsampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within one week prior to first docetaxel dose
Secondary outcomes (2)
relation between docetaxel toxicity and dose/LBM
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)
Measured: 1 cycle (21 days)
determine the best method to measure lean body mass
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.
Measured: within one week prior to first docetaxel dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rien Hoge, PharmD, Principal investigator, Deventer ZiekenhuisFrank Jansman, PharmD, PhD, Study chair, Deventer Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621425
- Sponsor's protocol ID
- UMCN-AKF 11.01
- Acronym
- LEANDOC
- Status last verified
- Aug 2015
- First submitted
- 25 May 2012
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity
- ClinicalTrials.gov ID
- NCT01621425
- Acronym / sponsor ID
- LEANDOC / UMCN-AKF 11.01
- Keywords
- breast cancer, prostate carcinoma, docetaxel, lean body mass, Body Surface Area, body weight, dexascan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAC regimen | – | Other: Lean body mass, Other: Total body weight, Other: bloodsamplingFemale subject diagnosed with breast carcinoma and will receive docetaxel treatment according to standard hospital protocol |
| PRODOC regimen | – | Other: Lean body mass, Other: Total body weight, Other: bloodsamplingmale subject diagnosed with metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lean body massLean Body mass (DEXA scan and Bioelectrical Impedance Assessments) within one week prior to the first docetaxel dose | Other | PRODOC regimen, TAC regimen |
| Total body weightTotal Body weight (TBW) (scale) within one week prior to the first docetaxel dose | Other | PRODOC regimen, TAC regimen |
| bloodsamplingBlood 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 | Other | PRODOC regimen, TAC regimen |
Primary outcome
anthropometric parameters related to exposure
Time frame: within one week prior to first docetaxel dose
To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC) for both males and females
2 secondary outcomes
relation between docetaxel toxicity and dose/LBM
Time frame: 1 cycle (21 days)
determine the best method to measure lean body mass
Time frame: within one week prior to first docetaxel dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rien Hoge, PharmD principal investigator
Deventer Ziekenhuis
Frank Jansman, PharmD, PhD study chair
Deventer Ziekenhuis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Metastatic Castration-resistant Prostate Carcinoma, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anthropometric parameters related to exposure (time frame: within one week prior to first docetaxel dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.