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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Charité Campus Virchow-Klinikum

Berlin, 13533, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paclitaxel

Drug

carboplatin

Drug

Sponsors and collaborators

Lead sponsor

North Eastern German Society of Gynaecological Oncology

Other

Registry information

Important dates

Study start: 1999
Primary completion: 2003
Study completion: 2004
First posted: Sep 15, 2005
Registry last updated: Mar 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed