Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer

Phase 1

Completed

• Conditions: Cervical Cancer; Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Sarcoma
• Interventions: Drug: carboplatin; Drug: pegylated liposomal doxorubicin hydrochloride

• Registration Number: NCT00032162
• 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.

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.

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2002-03-08
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-05
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-29
• Last Update Posted: 2012-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PLD	pegylated liposomal doxorubicin hydrochloride	dose finding study of PLD in combination with Carboplatin
PLD	carboplatin	dose finding study of PLD in combination with Carboplatin

Primary Outcome Measures

Name	Time	Method
DL DLT	DLT during first 3 cycles

Trial Locations

Locations (19)

Universitaetsklinikum Charite; 🇩🇪 Berlin, Germany

Zentralkrankenhaus; 🇩🇪 Bremen, Germany

Medizinische Klinik I; 🇩🇪 Dresden, Germany

Universitaetsklinik Duesseldorf; 🇩🇪 Duesseldorf, Germany

Universitaet Ulm; 🇩🇪 Ulm, Germany

Evangelisches Krankenhaus; 🇩🇪 Dusseldorf, Germany

Klinikum der J.W. Goethe Universitaet; 🇩🇪 Frankfurt, Germany

Universitaetsklinik Goettingen; 🇩🇪 Gottingen, Germany

Staedtisches Krankenhaus FFM-Hoechst; 🇩🇪 Frankfurt Am Main, Germany

Klinikum Rechts Der Isar/Technische Universitaet Muenchen; 🇩🇪 Munich (Muenchen), Germany

Vincentius Krankenhaus; 🇩🇪 Karlsruhe, Germany

Klinik und Poliklinik fuer Kinderheilkunde; 🇩🇪 Muenster, Germany

Klinikum Grosshadern; 🇩🇪 Munich (Muenchen), Germany

Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet; 🇩🇪 Greifswald, Germany

Frauenklinik der MHH; 🇩🇪 Hannover, Germany

Klinik der Otto - v. - Guericke - Universitat; 🇩🇪 Magdeburg, Germany

Christian-Albrechts University of Kiel; 🇩🇪 Kiel, Germany

Universitaetsklinikum Tuebingen; 🇩🇪 Tuebingen, Germany

Dr. Hors t- Schmidt - Kliniken; 🇩🇪 Wiesbaden, Germany