Spots Global Cancer Trial Database for Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
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Trial Identification
Brief Title: Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
Official Title: Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors
Study ID: NCT00032162
Study Description
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. PURPOSE: Phase I/II trial to study the effectiveness of combining liposomal doxorubicin with carboplatin in treating patients who have gynecologic cancer.
Detailed Description: OBJECTIVES: * Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with carboplatin in patients with gynecological tumors. * Determine the dose-limiting toxicity of this regimen in these patients. * Determine the kind, frequency, severity, and duration of adverse events in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of doxorubicin HCl liposome. Patients receive doxorubicin HCl liposome IV over 60 minutes followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 28 days for 6 courses. Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued and treated at the MTD as above. Patients are followed at 4-6 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 1 year.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Universitaetsklinikum Charite, Berlin, , Germany
Zentralkrankenhaus, Bremen, , Germany
Medizinische Klinik I, Dresden, , Germany
Universitaetsklinik Duesseldorf, Duesseldorf, , Germany
Evangelisches Krankenhaus, Dusseldorf, , Germany
Staedtisches Krankenhaus FFM-Hoechst, Frankfurt Am Main, , Germany
Klinikum der J.W. Goethe Universitaet, Frankfurt, , Germany
Universitaetsklinik Goettingen, Gottingen, , Germany
Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet, Greifswald, , Germany
Frauenklinik der MHH, Hannover, , Germany
Vincentius Krankenhaus, Karlsruhe, , Germany
Christian-Albrechts University of Kiel, Kiel, , Germany
Klinik der Otto - v. - Guericke - Universitat, Magdeburg, , Germany
Klinik und Poliklinik fuer Kinderheilkunde, Muenster, , Germany
Klinikum Grosshadern, Munich (Muenchen), , Germany
Klinikum Rechts Der Isar/Technische Universitaet Muenchen, Munich (Muenchen), , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
Universitaet Ulm, Ulm, , Germany
Dr. Hors t- Schmidt - Kliniken, Wiesbaden, , Germany
Contact Details
Name: Andreas du Bois, MD, PhD
Affiliation: Dr. Horst-Schmidt-Kliniken
Role: STUDY_CHAIR
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