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. Identifier: NCT00415181
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : January 13, 2015
Danish Clinical Intervention Research Academy
Ministry of the Interior and Health, Denmark
Information provided by:
University of Southern Denmark

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 in patients with ovarian cancer who receive 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 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.

Study Type : Observational
Actual Enrollment : 93 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Pharmacogenomics of Paclitaxel in Patients With Ovarian Cancer: Predictors of Toxicity and Response
Study Start Date : September 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Paclitaxel

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients diagnosed with ovarian cancer

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

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 identifier (NCT number): NCT00415181

Department of oncology, Herlev Hospital
Herlev, Denmark
Department of Oncology, Odense University Hospital
Odense, Denmark
Department of Oncology, Vejle Hospital
Vejle, Denmark
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
Study Director: Kim Brøsen, phd University of Southern Denmark

Publications of Results:
Responsible Party: Troels K Bergmann, University of Southern Denmark Identifier: NCT00415181     History of Changes
Other Study ID Numbers: AKF-319pro
First Posted: December 22, 2006    Key Record Dates
Last Update Posted: January 13, 2015
Last Verified: December 2006

Keywords provided by University of Southern Denmark:

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