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

CompletedOBSERVATIONAL
Enrollment

20

Participants

Timeline

Start Date

April 30, 2003

Primary Completion Date

January 31, 2004

Study Completion Date

March 31, 2009

Conditions
CYP3A PhenotypingCYP3A5 and MDR1 GenotypingDocetaxel ToxicityAssociations Between Genetic Data and Docetaxel Toxicity
Interventions
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."

Trial Locations (1)

20521

Turku University Hospital, Turku

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

collaborator

Turku University Hospital

OTHER_GOV

collaborator

Vaasa Central Hospital, Vaasa, Finland

OTHER

collaborator

medbase Oy Ltd

UNKNOWN

lead

University of Turku

OTHER