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Pharmacogenomics of Paclitaxel in Ovarian Cancer

This study has been completed.
Danish Clinical Intervention Research Academy
Ministry of the Interior and Health, Denmark
Information provided by:
University of Southern Denmark Identifier:
First received: December 21, 2006
Last updated: August 4, 2011
Last verified: December 2006
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.

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

Resource links provided by NLM:

Further study details as provided by University of Southern Denmark:

Biospecimen Retention:   Samples With DNA
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)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
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Please refer to this study by its identifier: NCT00415207

Clinical Pharmacology, University of Southern Denmark
Odense, Denmark
Sponsors and Collaborators
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

Responsible Party: Troels K Bergmann, University of Southern Denmark Identifier: NCT00415207     History of Changes
Other Study ID Numbers: WRAMC WU# 04-23009
Study First Received: December 21, 2006
Last Updated: August 4, 2011

Keywords provided by University of Southern Denmark:

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017