Status:
COMPLETED
Taxol/ Carboplatin as First Line Therapy in Patients With Epithelial Ovarian Cancer
Lead Sponsor:
North Eastern German Society of Gynaecological Oncology
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
The combination of paclitaxel and carboplatin in a three weeks schedule has emerged as the current standard approach for the adjuvant treatment of ovarian cancer. Based on a phase I study now a multi-...
Eligibility Criteria
Inclusion
- 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
- suffering from secondary malignancy or underlying serious, uncontrolled concurrent medical or psychiatric disease
- radiotherapy within 4 weeks for study entry
Key Trial Info
Start Date :
January 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00170664
Start Date
January 1 1999
End Date
September 1 2004
Last Update
March 25 2016
Active Locations (1)
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1
Charité Campus Virchow-Klinikum
Berlin, Germany, 13533