Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer
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|ClinicalTrials.gov Identifier: NCT00006454|
Recruitment Status : Completed
First Posted : February 3, 2004
Last Update Posted : December 23, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer||Drug: carboplatin Drug: paclitaxel Drug: topotecan hydrochloride||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase III Multicenter Study in Epithelial Ovarian Carcinoma FIGO Stage IIB-IV Comparing Treatment With Paclitaxel and Carboplatin to Paclitaxel and Carboplatin Sequentially Followed by Topotecan|
|Study Start Date :||December 1999|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||August 2006|
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): NCT00006454
|Berlin, Germany, D-10117|
|Bonn, Germany, D-53105|
|Bremen, Germany, D-28205|
|Medizinische Klinik I|
|Dresden, Germany, D-01307|
|Duesseldorf, Germany, D-40225|
|Dusseldorf, Germany, DOH-4-0217|
|Klinikum der J.W. Goethe Universitaet|
|Frankfurt, Germany, D-60590|
|Stadtische Kliniken Frankfurt-Hochst|
|Frankfurt, Germany, DOH-6-5929|
|Gottingen, Germany, D-37075|
|Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet|
|Greifswald, Germany, D-17487|
|Frauenklinik der MHH|
|Hannover, Germany, 30659|
|Karlsruhe, Germany, D-76137|
|Christian-Albrechts University of Kiel|
|Kiel, Germany, D-24105|
|Klinik der Otto-v.-Guericke-Universitat|
|Magdeburg, Germany, 39108|
|Klinik und Poliklinik fuer Kinderheilkunde|
|Muenster, Germany, D-48129|
|Munich, Germany, D-81377|
|Klinikum Rechts Der Isar/Technische Universitaet Muenchen|
|Munich, Germany, D-81675|
|Tuebingen, Germany, D-72076|
|Wiesbaden, Germany, D-65199|
|Study Chair:||Jacobus Pfisterer, MD||University of Schleswig-Holstein|