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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Paclitaxel
Carboplatin
Sponsored by
North Eastern German Society of Gynaecological Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian neoplasms, paclitaxel, carboplatin, clinical trials, phase II, first-line chemotherapy, weekly therapy schedule

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Charité Campus Virchow-Klinikum

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel, Carboplatin

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
March 24, 2016
Sponsor
North Eastern German Society of Gynaecological Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00170664
Brief Title
Taxol/ Carboplatin as First Line Therapy in Patients With Epithelial Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
North Eastern German Society of Gynaecological Oncology

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Ovarian neoplasms, paclitaxel, carboplatin, clinical trials, phase II, first-line chemotherapy, weekly therapy schedule

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel, Carboplatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Carboplatin

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Werner Lichtenegger
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13533
Country
Germany

12. IPD Sharing Statement

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

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