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

This study has been completed.
Sponsor:
Information provided by:
North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:
NCT00170664
First received: September 12, 2005
Last updated: March 24, 2016
Last verified: March 2016
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

  Eligibility

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

ClinicalTrials.gov Identifier: NCT00170664     History of Changes
Other Study ID Numbers: 020114 
Study First Received: September 12, 2005
Last Updated: March 24, 2016
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

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

ClinicalTrials.gov processed this record on July 28, 2016