Phase 2
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Female
Ovarian Cancer
Female
Ovarian Cancer
Trial Information
Inclusion Criteria:
- histologically-confirmed epithelial ovarian cancer of FIGO stage IIB - IV
- life expectancy of more than three months
- ECOG performance status less than 3
- laboratory parameters within the normal range, including a glomerular filtration rate
(GFR) greater than 60 ml/min, serum creatinine levels below 1.6 mg/dl, liver
transaminases less than two times the normal levels, bilirubin concentrations below
1.5 mg/dl, adequate bone marrow function as indicated by a neutrophil count greater
than 1,500/µl, and a platelet count greater than 100,000/µl.
- written informed consent
Exclusion Criteria:
- suffering from secondary malignancy or underlying serious, uncontrolled concurrent
medical or psychiatric disease
- radiotherapy within 4 weeks for study entry
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Principal Investigator
Werner Lichtenegger
Investigator Role:
Principal Investigator
Investigator Affiliation:
Charité Campus Virchow Klinikum
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
020114
NCT ID:
NCT00170664
Start Date:
Completion Date:
Related Keywords:
- Ovarian Cancer
- - Ovarian neoplasms
- – paclitaxel, carboplatin
- – clinical trials, phase II
- – first-line chemotherapy
- - weekly therapy schedule
- Ovarian Neoplasms
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