Pharmacogenomics of Paclitaxel in Ovarian Cancer
The Pharmacogenomics of Paclitaxel in Patients With Ovarian Cancer: Predictors of Toxicity and Response
1 other identifier
observational
93
2 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2006
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 21, 2006
CompletedFirst Posted
Study publicly available on registry
December 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJanuary 13, 2015
December 1, 2006
2.3 years
December 21, 2006
January 12, 2015
Conditions
Keywords
Eligibility Criteria
patients diagnosed with ovarian cancer
You may qualify if:
- 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)
- years or older
- Caucasian (ie.parents and grandparents are Caucasian)
- Performance status 2 or lower (after WHO/ECOG)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
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
Related Publications (1)
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.
PMID: 20368717RESULT
Biospecimen
blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kim Brøsen, phd
University of Southern Denmark
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 21, 2006
First Posted
December 22, 2006
Study Start
September 1, 2006
Primary Completion
January 1, 2009
Study Completion
March 1, 2013
Last Updated
January 13, 2015
Record last verified: 2006-12