Pharmacogenomics of Paclitaxel in Ovarian Cancer

This study has been completed.
Sponsor:
Collaborators:
Danish Clinical Intervention Research Academy
Ministry of the Interior and Health, Denmark
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT00415207
First received: December 21, 2006
Last updated: August 4, 2011
Last verified: December 2006
  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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with ovarian cancer

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415207

Locations
Denmark
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
Investigators
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 April 17, 2014