Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity (LEANDOC)
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First Received Date ICMJE | May 25, 2012 | ||||||||
Last Updated Date | June 15, 2012 | ||||||||
Start Date ICMJE | June 2012 | ||||||||
Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01621425 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity | ||||||||
Official Title ICMJE | Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity | ||||||||
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. |
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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. |
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Study Type ICMJE | Observational | ||||||||
Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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Biospecimen | Retention: Samples Without DNA Description: Blood samples for docetaxel concentration measurement (n=4) |
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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) |
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Condition ICMJE |
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Intervention ICMJE |
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Study Group/Cohort (s) |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE | 40 | ||||||||
Estimated Completion Date | May 2013 | ||||||||
Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Netherlands | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01621425 | ||||||||
Other Study ID Numbers ICMJE | UMCN-AKF 11.01 | ||||||||
Has Data Monitoring Committee | No | ||||||||
Responsible Party | Radboud University | ||||||||
Study Sponsor ICMJE | Radboud University | ||||||||
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Investigators ICMJE |
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Information Provided By | Radboud University | ||||||||
Verification Date | June 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |