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Pharmacogenomics of Paclitaxel in Ovarian Cancer: Predictors of Toxicity and Response


N/A
18 Years
N/A
Not Enrolling
Female
Ovarian Neoplasms, Fallopian Tube Neoplasms

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Trial Information

Pharmacogenomics of Paclitaxel in Ovarian Cancer: Predictors of Toxicity and Response


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.


Inclusion Criteria:



- Patients enrolled in "TC/TEC" in Denmark, Sweden or Norway

- Patients enrolled in "OVAR-9" in Denmark, Sweden or Norway

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Principal Investigator

Kim Brøsen, phd

Investigator Role:

Study Director

Investigator Affiliation:

University of Southern Denmark

Authority:

Denmark: Danish Dataprotection Agency

Study ID:

WRAMC WU# 04-23009

NCT ID:

NCT00415207

Start Date:

December 2006

Completion Date:

December 2010

Related Keywords:

  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • CYP2C8
  • MDR1
  • Pharmacogenetics
  • Paclitaxel
  • Neoplasms
  • Fallopian Tube Neoplasms
  • Ovarian Neoplasms

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