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Spots Global Cancer Trial Database for Pharmacogenomics of Paclitaxel in Ovarian Cancer

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Trial Identification

Brief Title: Pharmacogenomics of Paclitaxel in Ovarian Cancer

Official Title: Pharmacogenomics of Paclitaxel in Ovarian Cancer: Predictors of Toxicity and Response

Study ID: NCT00415207

Interventions

Study Description

Brief Summary: This study will try to determine whether or not certain genes are responsible for the huge variation in toxicity and effect observed between patients treated with paclitaxel (chemotherapeutic drug). Specifically we will study this retrospectively in patients who participated in clinical trials that are now closed. All patients had ovarian cancer and received paclitaxel/carboplatin chemotherapy after primary surgery.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Clinical Pharmacology, University of Southern Denmark, Odense, , Denmark

Contact Details

Name: Kim Brøsen, phd

Affiliation: University of Southern Denmark

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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