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

This study has been completed.
Information provided by:
North Eastern Germany Society of Gynaecologic Oncology Identifier:
First received: September 12, 2005
Last updated: March 24, 2016
Last verified: March 2016
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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by North Eastern Germany Society of Gynaecologic Oncology:

Enrollment: 129
Study Start Date: January 1999
Study Completion Date: September 2004
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel, Carboplatin Drug: Paclitaxel Drug: Carboplatin


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00170664

Charité Campus Virchow-Klinikum
Berlin, Germany, 13533
Sponsors and Collaborators
North Eastern Germany Society of Gynaecologic Oncology
Principal Investigator: Werner Lichtenegger Charite University, Berlin, Germany
  More Information Identifier: NCT00170664     History of Changes
Other Study ID Numbers: 020114
Study First Received: September 12, 2005
Last Updated: March 24, 2016

Keywords provided by North Eastern Germany Society of Gynaecologic Oncology:
Ovarian neoplasms
paclitaxel, carboplatin
clinical trials, phase II
first-line chemotherapy
weekly therapy schedule

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017