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Ovarian NeoplasmsNCT00415181

Pharmacogenomics of Paclitaxel in Ovarian Cancer

An observational study of Ovarian Neoplasms and Fallopian Tube Neoplasms, run by University of Southern Denmark at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Neoplasms, Fallopian Tube Neoplasms
How many people
93 participants
Where
4 sitesin 2 countries
Study dates
Sep 2006to Mar 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: patients diagnosed with ovarian cancer

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Denmark3 sites

  • Department of oncology, Herlev Hospital

    Herlev

  • Department of Oncology, Odense University Hospital

    Odense

  • Department of Oncology, Vejle Hospital

    Vejle

Other trials in Denmark

Sweden1 site

  • Department of Oncology, University Hospital of Lund

    Lund

Other trials in Sweden

About this study

Official title: The Pharmacogenomics of Paclitaxel in Patients With Ovarian Cancer: Predictors of Toxicity and Response

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.

Read the 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.

Keywords
CYP2C8, MDR1, Pharmacogenetics, Paclitaxel
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionJan 2009
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00415181
Sponsor's protocol ID
AKF-319pro
Status last verified
Dec 2006
First submitted
21 Dec 2006
Last updated
13 Jan 2015
Results posted
No

Publications

  • Bergmann TK, Brasch-Andersen C, Green H, Mirza M, Pedersen RS, Nielsen F, Skougaard K, Wihl J, Keldsen N, Damkier P, Friberg LE, Peterson C, Vach W, Karlsson MO, Brosen K. Impact of CYP2C8*3 on paclitaxel clearance: a population pharmacokinetic and pharmacogenomic study in 93 patients with ovarian cancer. Pharmacogenomics J. 2011 Apr;11(2):113-20. doi: 10.1038/tpj.2010.19. Epub 2010 Apr 6.

    PubMed 20368717

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Neoplasms and Fallopian Tube Neoplasms, run by University of Southern Denmark at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00415181, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2015.

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