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Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer

2014-08-27 03:56:18 | BioPortfolio

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.

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 Design

Primary Purpose: Treatment

Conditions

Cervical Cancer

Intervention

carboplatin, pegylated liposomal doxorubicin hydrochloride

Location

Universitaetsklinikum Charite
Berlin
Germany
D-10117

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:18-0400

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