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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: November 8, 2005
Last verified: September 2005
History of Changes
  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: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:

U.S. FDA Resources

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

  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

No publications provided

ClinicalTrials.gov Identifier: NCT00170664     History of Changes
Other Study ID Numbers: 020114
Study First Received: September 12, 2005
Last Updated: November 8, 2005
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
 Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 17, 2013