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| Sponsors and Collaborators: |
University of Southern Denmark Danish Clinical Intervention Research Academy Ministry of the Interior and Health, Denmark |
| Information provided by: | University of Southern Denmark |
| ClinicalTrials.gov Identifier: | NCT00415207 |
Purpose
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.
| Condition |
|
Ovarian Neoplasms Fallopian Tube Neoplasms |
| MedlinePlus related topics: | Cancer Ovarian Cancer |
| ChemIDplus related topics: | Paclitaxel |
| Study Type: | Observational |
| Study Design: | Screening, Longitudinal, Defined Population, Retrospective Study |
| Official Title: | Pharmacogenomics of Paclitaxel in Ovarian Cancer: Predictors of Toxicity and Response |
| Estimated Enrollment: | 300 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | February 2009 |
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
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: Troels K Bergmann, MD | +45 61704711 | placebo@halian.dk |
| Denmark | |||||
| Clinical Pharmacology, University of Southern Denmark | Recruiting | ||||
| Odense, Denmark | |||||
| University of Southern Denmark |
| Danish Clinical Intervention Research Academy |
| Ministry of the Interior and Health, Denmark |
| Study Director: | Kim Brøsen, phd | University of Southern Denmark |
More Information
| Study ID Numbers: | WRAMC WU# 04-23009 |
| First Received: | December 21, 2006 |
| Last Updated: | December 21, 2006 |
| ClinicalTrials.gov Identifier: | NCT00415207 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
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