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

Phase 2

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: Paclitaxel; Drug: Carboplatin

• Registration Number: NCT00170664
• Lead Sponsor: North Eastern German Society of Gynaecological Oncology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-01
• Primary Completion: 2003-03
• Study Completion: 2004-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-24
• Last Update Posted: 2016-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 129

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel, Carboplatin	Paclitaxel	-
Paclitaxel, Carboplatin	Carboplatin	-

Trial Locations

Locations (1)

Charité Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany