Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
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|ClinicalTrials.gov Identifier: NCT00032162|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 31, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Sarcoma||Drug: carboplatin Drug: pegylated liposomal doxorubicin hydrochloride||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors|
|Study Start Date :||August 2001|
|Actual Primary Completion Date :||May 2005|
dose finding study of PLD in combination with Carboplatin
AUC 6 q4wDrug: pegylated liposomal doxorubicin hydrochloride
20/30/40 mg/qm q4w Dose finding study
- DL DLT [ Time Frame: DLT during first 3 cycles ]
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): NCT00032162
|Berlin, Germany, D-10117|
|Bremen, Germany, D-28205|
|Medizinische Klinik I|
|Dresden, Germany, D-01307|
|Duesseldorf, Germany, D-40225|
|Dusseldorf, Germany, DOH-40217|
|Staedtisches Krankenhaus FFM-Hoechst|
|Frankfurt Am Main, Germany, 65929|
|Klinikum der J.W. Goethe Universitaet|
|Frankfurt, Germany, 60596|
|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 (Muenchen), Germany, D-81377|
|Klinikum Rechts Der Isar/Technische Universitaet Muenchen|
|Munich (Muenchen), Germany, D-81675|
|Tuebingen, Germany, D-72076|
|Ulm, Germany, D-89075|
|Dr. Hors t- Schmidt - Kliniken|
|Wiesbaden, Germany, D-65199|
|Study Chair:||Andreas du Bois, MD, PhD||Dr. Horst-Schmidt-Kliniken|