Study of Usefulness of Genotyping to Predict Docetaxel Exposure and Adverse Events (Docetaxel)
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|ClinicalTrials.gov Identifier: NCT01110291|
Recruitment Status : Completed
First Posted : April 26, 2010
Last Update Posted : April 27, 2010
Twenty patients with verified high risk breast cancer will be included in the study. Patients will receive three cycles of docetaxel followed by three cycles of CEF for their adjuvant treatment. The phenotype of CYP3A and the genotype of CYP3A5 and MDR1 will be assessed. Also the effect of docetaxel in the activity of CYP3A will be measured by peroral midazolam.
The primary object of this study is to define, if it is possible to predict the clearance and/ or toxicity of docetaxel by assessing
- activity of CYP3A4 by midazolam test (CYP3A4 phenotype)
- CYP3A5 genotype
- MDR1 genotype
The secondary object of this study is to define whether the treatment with docetaxel alters the activity of CYP3A4 enzyme in previously untreated breast cancer patients.
|Condition or disease||Intervention/treatment|
|CYP3A Phenotyping CYP3A5 and MDR1 Genotyping Docetaxel Toxicity Associations Between Genetic Data and Docetaxel Toxicity||Drug: docetaxel + CEF|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Activity of CYP3A and Genotypes of CYP3A5 and MDR1 as Predictors of the Clearance and Adverse Effects of Docetaxel, and the Effect of Docetaxel to CYP3A Activity in Previously Untreated Breast Cancer Patients|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||January 2004|
|Actual Study Completion Date :||March 2009|
Twenty patients with verified high risk breast cancer will be included in the study.
Drug: docetaxel + CEF
Docetaxel 80 mg/m² of body surface area (BSA) will be given as an i.v. infusion during 60 minutes on day 0 in a 20-day schedule. The cycle is repeated three times.
Three weeks after the last docetaxel regimen, all patients will receive the CEF-combination treatment. In CEF-combination cyclophosphamide will be given 600 mg/m²of BSA as an i.v. infusion during 15 - 30 minutes on day 0 in a 20-day schedule. This is followed by fluorouracil given 600 mg/m² of BSA as an i.v. infusion during 15 - 30 minutes . Epirubicin will be given 60 mg/m² of BSA as an i.v. infusion during 15 - 30 minutes. This combination therapy will be repeated three times.
- docetaxel toxicityThere were no specific outcome measures in this study. The chemotherapy was given in a predetermined schedule and additionally blood samples were drawn for genotyping. The adverse events were recorded and compared with the data from genotyping.
- survivalNo specific outcome measures. Survival data was collected and compared with the data from genotyping.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110291
|Turku University Hospital|
|Turku, Finland, 20521|
|Principal Investigator:||Johanna Hilli, MD, PhD||Department of Pharmacology, Drug Development and Therapeutics, University of Turku, Turku, Finland|
|Study Chair:||Liisa Sailas, MD||Department of Oncology, Vaasa Central Hospital, Vaasa, Finland|
|Study Chair:||Sirkku Jyrkkiö, MD, PhD||Department of Oncology and Radiotherapy, Turku University Hospital, Turku, Finland|
|Study Chair:||Seppo Pyrhönen, MD, PhD||Department of Oncology and Radiotherapy, Turku University Hospital, Turku, Finland|
|Study Chair:||Kari Laine, MD, PhD||medbase Oy Ltd, Turku, Finland|