Ovarian Cancer
Conditions
Keywords
Ovarian neoplasms, paclitaxel, carboplatin, clinical trials, phase II, first-line chemotherapy, weekly therapy schedule
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-center phase II-trial was conducted.
Interventions
Sponsors
Study design
Eligibility
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
Countries
Germany