Pharmacogenomics of Paclitaxel in Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00415181|
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : January 13, 2015
|Condition or disease|
|Ovarian Neoplasms Fallopian Tube Neoplasms|
Paclitaxel is an antineoplastic drug used in the treatment of ovarian cancer. The effect and toxicity is unpredictable in the individual patient. Paclitaxel is removed (eliminated) from the organism by oxidation. CYP2C8 is the enzyme mainly responsible. P-glycoprotein (Pgp) is an efflux transport protein natural to the human organism. Pgp is responsible for excretion of drugs via the bile and the kidneys and is thought to play a role in chemotherapy resistance. Paclitaxel is substrate for Pgp. Single nucleotide polymorphisms are possible causes for variation in both CYP2C8 and Pgp expression/function. We will study a possible role of these genetic variations as predictors of paclitaxel toxicity and effect and the possible implications for individual dosing in the future.
We want to determine the metabolic capacity of approximately 100 ovarian cancer patients and comparing this with genotypes, acute toxicity(eg. bone marrow suppression and neuropathy) and response to treatment(ie. CA125 response, progression free survival and overall survival). The metabolic capacity is estimated using a "sparse sampling" approach applying advanced computerized pharmacokinetic/dynamic modelling as opposed to traditional "frequent sampling" pharmacokinetic studies which burden the individual patient more.
Patients are recruited in collaboration with Oncological departments throughout Scandinavia.
|Study Type :||Observational|
|Actual Enrollment :||93 participants|
|Official Title:||The Pharmacogenomics of Paclitaxel in Patients With Ovarian Cancer: Predictors of Toxicity and Response|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||March 2013|
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): NCT00415181
|Department of oncology, Herlev Hospital|
|Department of Oncology, Odense University Hospital|
|Department of Oncology, Vejle Hospital|
|Department of Oncology, University Hospital of Lund|
|Study Director:||Kim Brøsen, phd||University of Southern Denmark|