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

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ClinicalTrials.gov Identifier: NCT00170664
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : March 25, 2016
Sponsor:
Information provided by:
North Eastern Germany Society of Gynaecologic Oncology

Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Cancer Drug: Paclitaxel Drug: Carboplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 1999
Actual Primary Completion Date : March 2003
Actual Study Completion Date : September 2004


Arm Intervention/treatment
Experimental: Paclitaxel, Carboplatin Drug: Paclitaxel Drug: Carboplatin




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Charite University, Berlin, Germany

ClinicalTrials.gov Identifier: NCT00170664     History of Changes
Other Study ID Numbers: 020114
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 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
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