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Pharmacogenomics of Paclitaxel in Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00415207
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : August 8, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief 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.

Condition or disease
Ovarian Neoplasms Fallopian Tube Neoplasms

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.


Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pharmacogenomics of Paclitaxel in Ovarian Cancer: Predictors of Toxicity and Response
Study Start Date : December 2006
Primary Completion Date : August 2008
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Biospecimen Retention:   Samples With DNA
paraffin embedded biopsies

Eligibility Criteria

Information from the National Library of Medicine

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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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: December 22, 2006    Key Record Dates
Last Update Posted: August 8, 2011
Last Verified: December 2006

Keywords provided by University of Southern Denmark:
CYP2C8
MDR1
Pharmacogenetics
Paclitaxel

Additional relevant MeSH terms:
Neoplasms
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
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action