A Phase I/II Study of Intravenous Doxil and Intraperitoneal Carboplatin as Salvage Therapy in Patients With Recurrent Ovarian Cancer
- To determine the maximum tolerated dose and safety of intravenous doxorubicin
hydrochloride and intraperitoneal carboplatin in patients with platinum-sensitive
recurrent ovarian cancer.
- To evaluate the feasibility of this regimen in these patients.
- To evaluate the response rate and progression-free survival of patients with recurrent
ovarian cancer who have had no more than two prior salvage regimens.
OUTLINE: This is a phase I dose-escalation study of carboplatin followed by a phase II
- Phase I: Patients receive doxorubicin hydrochloride IV over 1 hour followed by
carboplatin intraperitoneally on day 1 until the maximum tolerated dose is achieved.
Treatment repeats every 28 days for 6 courses in the absence of disease progression or
- Phase II: Patients receive doxorubicin hydrochloride as in phase I and carboplatin at
the maximum tolerated dose as in phase I.
After completion of study treatment, patients are followed every 4 weeks for 1 year.
PROJECTED ACCRUAL: A total of 61 patients (18 patients in phase I and 43 patients in phase
II) will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Jayanthi S. Lea, MD
Simmons Cancer Center
United States: Federal Government
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|