Finding studies
Finding studies
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Lead
University of Texas Southwestern Medical Center
With
OBJECTIVES: Primary * 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. Secondary * 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 study. * 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 unacceptable toxicity. * 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.
Age
18–120
Sex
FEMALE
Healthy volunteers
Not accepted
