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

December 21, 2006
August 4, 2011
December 2006
August 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00415207 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacogenomics of Paclitaxel in Ovarian Cancer
Pharmacogenomics of Paclitaxel in Ovarian Cancer: Predictors of Toxicity and Response

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

paraffin embedded biopsies

Non-Probability Sample

Patients with ovarian cancer

  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
Not Provided
Not Provided
Bergmann TK, Gréen H, Brasch-Andersen C, Mirza MR, Herrstedt J, Hølund B, du Bois A, Damkier P, Vach W, Brosen K, Peterson C. Retrospective study of the impact of pharmacogenetic variants on paclitaxel toxicity and survival in patients with ovarian cancer. Eur J Clin Pharmacol. 2011 Jul;67(7):693-700. doi: 10.1007/s00228-011-1007-6. Epub 2011 Feb 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
December 2010
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients enrolled in "TC/TEC" in Denmark, Sweden or Norway
  • Patients enrolled in "OVAR-9" in Denmark, Sweden or Norway
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00415207
WRAMC WU# 04-23009
Not Provided
Troels K Bergmann, University of Southern 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
University of Southern Denmark
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP