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Study of Usefulness of Genotyping to Predict Docetaxel Exposure and Adverse Events

Information source: University of Turku
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: CYP3A Phenotyping; CYP3A5 and MDR1 Genotyping; Docetaxel Toxicity; Associations Between Genetic Data and Docetaxel Toxicity

Intervention: docetaxel + CEF (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Turku

Official(s) and/or principal investigator(s):
Johanna Hilli, MD, PhD, Principal Investigator, Affiliation: Department of Pharmacology, Drug Development and Therapeutics, University of Turku, Turku, Finland
Liisa Sailas, MD, Study Chair, Affiliation: Department of Oncology, Vaasa Central Hospital, Vaasa, Finland
Sirkku Jyrkkiö, MD, PhD, Study Chair, Affiliation: Department of Oncology and Radiotherapy, Turku University Hospital, Turku, Finland
Seppo Pyrhönen, MD, PhD, Study Chair, Affiliation: Department of Oncology and Radiotherapy, Turku University Hospital, Turku, Finland
Kari Laine, MD, PhD, Study Chair, Affiliation: medbase Oy Ltd, Turku, Finland

Summary

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. Primary Object: 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

Secondary object: 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.

Clinical Details

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 design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: docetaxel toxicity

Secondary outcome: survival

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Female.

Criteria:

Inclusion Criteria: Subjects may be included in the study only if they meet all of the following criteria: 1. The patient has received information on the purpose of the study and the meaning of the treatment, and has given verbal and written consent to participate in the study. The patient is accessible for treatment and follow-up. 2. Histologically verified diagnosis of breast cancer 3. High risk for recurrence ( node positive or node negative if T2 with histological grade 2 or 3, or Pgr negative) 4. No metastases 5. Females, age =<60 6. No concomitant regular medication which is either substrate, inducer or inhibitor of CYP3A4 Exclusion Criteria: Subjects will be excluded from the study for any of the following reasons: 1. Poor performance status,>=2 according to WHO 2. Inadequate bone marrow reserve defined as:

- hemoglobin < 100 g/L

- leukocytes < 3. 0 x 10E9/L or neutrophiles < 1. 5 x 10E9/L

- plateless < 120 x 10E9/L

3. Inadequate liver function defined as:

- ALAT is > 1. 5 x units of normal level

- elevated bilirubin (unless verified Gilbert´s syndrome)

- alkaline phosphatase is > 2. 5 x units of normal level

4. History of concomitant serious physical or psychiatric disease, which makes a regular cytotoxic treatment impossible 5. cardiac insufficience; severe arrhythmia; severe hypertension; cardiac infarction within one year or other active cardiac disease 6. pregnant or lactating patients 7. abuse of alcohol or any narcotic substances

Locations and Contacts

Turku University Hospital, Turku 20521, Finland
Additional Information

Starting date: April 2003
Last updated: April 26, 2010

Page last updated: August 23, 2015

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