Pharmacogenomics of Paclitaxel in Ovarian Cancer
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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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Pharmacogenomics of Paclitaxel in Ovarian Cancer: Predictors of Toxicity and Response |
paraffin embedded biopsies
| Estimated Enrollment: | 300 |
| Study Start Date: | December 2006 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
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 |
| Sampling Method: | Non-Probability Sample |
Patients with ovarian cancer
Inclusion Criteria:
- Patients enrolled in "TC/TEC" in Denmark, Sweden or Norway
- Patients enrolled in "OVAR-9" in Denmark, Sweden or Norway
Contacts and Locations| Denmark | |
| Clinical Pharmacology, University of Southern Denmark | |
| Odense, Denmark | |
| Study Director: | Kim Brøsen, phd | University of Southern Denmark |
More Information
Publications:
| Responsible Party: | Troels K Bergmann, University of Southern Denmark |
| ClinicalTrials.gov Identifier: | NCT00415207 History of Changes |
| Other Study ID Numbers: | WRAMC WU# 04-23009 |
| Study First Received: | December 21, 2006 |
| Last Updated: | August 4, 2011 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
Keywords provided by University of Southern Denmark:
|
CYP2C8 MDR1 Pharmacogenetics Paclitaxel |
Additional relevant MeSH terms:
|
Neoplasms Fallopian Tube Neoplasms Ovarian Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Endocrine Gland Neoplasms Ovarian Diseases |
Endocrine System Diseases Gonadal Disorders Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013