Pharmacogenomics of Paclitaxel in Ovarian Cancer

Ovarian Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415207
• Other study ID #: WRAMC WU# 04-23009
• Status: Completed
• Phase: N/A
• First received: December 21, 2006
• Last updated: August 4, 2011
• Start date: December 2006
• Est. completion date: December 2010

Study information

• Verified date: December 2006
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2010
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Fallopian Tube Neoplasms
• Neoplasms
• Ovarian Neoplasms

Locations

Country	Name	City	State
Denmark	Clinical Pharmacology, University of Southern Denmark	Odense

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Danish Clinical Intervention Research Academy, Ministry of the Interior and Health, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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 — View Citation