Taxol/ Carboplatin as First Line Therapy in Patients With Epithelial Ovarian Cancer

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: North Eastern German Society of Gynaecological Oncology; North Eastern Germany Society of Gynaecologic Oncology
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

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