Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer
- Conditions
- Fallopian Tube CancerOvarian Cancer
- Registration Number
- NCT00006454
- Lead Sponsor
- AGO Study Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if paclitaxel plus carboplatin is more effective with or without topotecan for ovarian epithelial cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel plus carboplatin with or without topotecan in treating patients who have stage IIB, stage III, or stage IV ovarian epithelial cancer.
- Detailed Description
OBJECTIVES: I. Compare survival of patients with stage IIB, III, or IV ovarian epithelial carcinoma after receiving treatment with paclitaxel and carboplatin with or without topotecan. II. Compare progression-free survival of these patients after receiving these treatment regimens. III. Compare the response rate and response duration in these patients treated with these regimens. IV. Determine the toxic effects of the combination of paclitaxel, carboplatin, and topotecan in these patients. V. Compare the toxic effects of these treatment regimens in these patients. VI. Compare quality of life of these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and stage (stage IIB and stage III optimally debulked to no greater than 1 cm residual tumor vs stage IV regardless of residual tumor or residual tumor greater than 1 cm). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 0.5-1 hour on day 1 and topotecan IV over 0.5 hour on days 1-5. Treatment repeats every 21 days for 6 courses (topotecan is administered for 4 courses only). Arm II: Patients receive paclitaxel and carboplatin as in arm I. Treatment repeats every 21 days for 6 courses. Quality of life is assessed before courses 1, 3, and 5 and at 3 weeks and 3 months after completion of treatment in both treatment arms; before courses 1 and 3 of topotecan in arm I; and at 6 months after completion of treatment in arm II. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 914 patients (457 per treatment arm) will be accrued for this study over 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Medizinische Klinik I
🇩🇪Dresden, Germany
Christian-Albrechts University of Kiel
🇩🇪Kiel, Germany
Zentralkrankenhaus
🇩🇪Bremen, Germany
Universitaetsklinikum Charite
🇩🇪Berlin, Germany
Vincentius Krankenhaus
🇩🇪Karlsruhe, Germany
Universitaetsklinik Duesseldorf
🇩🇪Duesseldorf, Germany
Evangelisches Krankenhaus
🇩🇪Dusseldorf, Germany
Klinikum der J.W. Goethe Universitaet
🇩🇪Frankfurt, Germany
Stadtische Kliniken Frankfurt-Hochst
🇩🇪Frankfurt, Germany
Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
🇩🇪Greifswald, Germany
Universitaetsklinik Goettingen
🇩🇪Gottingen, Germany
Klinik und Poliklinik fuer Kinderheilkunde
🇩🇪Muenster, Germany
Universitaetskliniken Bonn
🇩🇪Bonn, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Klinik der Otto-v.-Guericke-Universitat
🇩🇪Magdeburg, Germany
Klinikum Grosshadern
🇩🇪Munich, Germany
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
🇩🇪Munich, Germany
Dr. Horst-Schmidt-Kliniken
🇩🇪Wiesbaden, Germany
Frauenklinik der MHH
🇩🇪Hannover, Germany