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Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors
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.
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Universitaetsklinikum Charite
Berlin, Germany
Zentralkrankenhaus
Bremen, Germany
Medizinische Klinik I
Dresden, Germany
Universitaetsklinik Duesseldorf
Düsseldorf, Germany
Evangelisches Krankenhaus
Düsseldorf, Germany
Klinikum der J.W. Goethe Universitaet
Frankfurt, Germany
Staedtisches Krankenhaus FFM-Hoechst
Frankfurt am Main, Germany
Universitaetsklinik Goettingen
Göttingen, Germany
Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, Germany
Frauenklinik der MHH
Hanover, Germany
Start Date
August 1, 2001
Primary Completion Date
May 1, 2005
Last Updated
May 31, 2012
63
ACTUAL participants
carboplatin
DRUG
pegylated liposomal doxorubicin hydrochloride
DRUG
Lead Sponsor
AGO Study Group
NCT05489211
NCT05281471
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