Pharmacogenomics of Paclitaxel in Ovarian Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00415207|
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : August 8, 2011
|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 will use tissue from patients who participated in one of two clinical trials that are both closed for inclusion. Genotypic data from this tissue will be correlated with toxicity and survival data drawn from a research database. We expect to be able to find >300 available cases to study.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Pharmacogenomics of Paclitaxel in Ovarian Cancer: Predictors of Toxicity and Response|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||December 2010|
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): NCT00415207
|Clinical Pharmacology, University of Southern Denmark|
|Study Director:||Kim Brøsen, phd||University of Southern Denmark|