Pharmacogenomics of Paclitaxel in Ovarian Cancer

NCT00415181CompletedOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

University of Southern Denmark

Enrollment

93

Start Date

2006-09-01

Completion Date

2009-01-01

Study Type

OBSERVATIONAL

Official Title

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

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Locations

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

Pharmacogenomics of Paclitaxel in Ovarian Cancer