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

This study has been completed.

Sponsored by:	North Eastern Germany Society of Gynaecologic Oncology
Information provided by:	North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:	NCT00170664

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer	Drug: Paclitaxel Drug: Carboplatin	Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Carboplatin Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Single Group Assignment

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170664

Locations

Germany
Charité Campus Virchow-Klinikum
Berlin, Germany, 13533

Sponsors and Collaborators

North Eastern Germany Society of Gynaecologic Oncology

Investigators

Principal Investigator:

Werner Lichtenegger

Charité Campus Virchow Klinikum

More Information

Study ID Numbers:	020114
Study First Received:	September 12, 2005
Last Updated:	November 8, 2005
ClinicalTrials.gov Identifier:	NCT00170664
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by North Eastern Germany Society of Gynaecologic Oncology:

- Ovarian neoplasms
– paclitaxel, carboplatin
– clinical trials, phase II
– first-line chemotherapy
- weekly therapy schedule

Study placed in the following topic categories:

Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases

Carboplatin
Ovarian epithelial cancer
Genital Diseases, Female
Paclitaxel
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009