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

Ovarian Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170664
• Other study ID #: 020114
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: March 24, 2016
• Start date: January 1999
• Est. completion date: September 2004

Study information

• Verified date: March 2016
• Source: North Eastern Germany Society of Gynaecologic Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: September 2004
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Paclitaxel

• Carboplatin

Locations

Country	Name	City	State
Germany	Charité Campus Virchow-Klinikum	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
North Eastern Germany Society of Gynaecologic Oncology

Country where clinical trial is conducted

Germany,