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Pharmacogenomics of Paclitaxel in Ovarian Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by University of Southern Denmark.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Danish Clinical Intervention Research Academy
Ministry of the Interior and Health, Denmark
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT00415181
First received: December 21, 2006
Last updated: June 22, 2012
Last verified: December 2006
History of Changes
  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 in patients with ovarian cancer who receive paclitaxel/carboplatin chemotherapy after primary surgery.


Condition
Ovarian Neoplasms
Fallopian Tube Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Pharmacogenomics of Paclitaxel in Patients With Ovarian Cancer: Predictors of Toxicity and Response

Resource links provided by NLM:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by University of Southern Denmark:

Biospecimen Retention:   Samples With DNA

blood


Estimated Enrollment: 100
Study Start Date: September 2006
Estimated Study Completion Date: March 2013
Primary Completion Date: January 2009 (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 want to determine the metabolic capacity of approximately 100 ovarian cancer patients and comparing this with genotypes, acute toxicity(eg. bone marrow suppression and neuropathy) and response to treatment(ie. CA125 response, progression free survival and overall survival). The metabolic capacity is estimated using a "sparse sampling" approach applying advanced computerized pharmacokinetic/dynamic modelling as opposed to traditional "frequent sampling" pharmacokinetic studies which burden the individual patient more.

Patients are recruited in collaboration with Oncological departments throughout Scandinavia.

  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 diagnosed with ovarian cancer

Criteria

Inclusion Criteria:

  • Clinical diagnose and histology of invasive epithelial ovarian/tuba or peritoneal cancer
  • FIGO stage IIb-IV any grade or FIGO Ia-IIa only grade 3 or clear cell carcinoma (any stage and grade)
  • Natural candidate for paclitaxel 175mg/m2 + Carboplatin (AUC=5-6)
  • Baseline CA125≥70 AND/OR evaluable disease after RECIST (incl ultrasound)
  • 18 years or older
  • Caucasian (ie.parents and grandparents are Caucasian)
  • Performance status 2 or lower (after WHO/ECOG)

Exclusion Criteria:

  • Prior malignant disease apart from cervical carcinoma in situ and basal cell carcinoma of the skin
  • Prior chemo / radiotherapy
  • Ongoing or imminent other chemotherapies
  • Pregnant or lactating
  • Fertile woman of childbearing potential not willing to use adequate contraception
  • Neurological symptoms (any kind) worse than CTCAE grade 1
  • Active infection or other serious disease that could impair on treatment and/or follow-up
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415181

Locations
Denmark
Department of oncology, Herlev Hospital
Herlev, Denmark
Department of Oncology, Odense University Hospital
Odense, Denmark
Department of Oncology, Vejle Hospital
Vejle, Denmark
Sweden
Department of Oncology, University Hospital of Lund
Lund, Sweden
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: NCT00415181     History of Changes
Other Study ID Numbers: AKF-319pro
Study First Received: December 21, 2006
Last Updated: June 22, 2012
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 May 19, 2013