Status:
COMPLETED
Pharmacogenomics of Paclitaxel in Ovarian Cancer
Lead Sponsor:
University of Southern Denmark
Collaborating Sponsors:
Danish Clinical Intervention Research Academy
Ministry of the Interior and Health, Denmark
Conditions:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Eligibility:
FEMALE
18+ years
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). S...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00415181
Start Date
September 1 2006
End Date
March 1 2013
Last Update
January 13 2015
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of oncology, Herlev Hospital
Herlev, Denmark
2
Department of Oncology, Odense University Hospital
Odense, Denmark
3
Department of Oncology, Vejle Hospital
Vejle, Denmark
4
Department of Oncology, University Hospital of Lund
Lund, Sweden