Ovarian Cancer Clinical Trial
Official title:
A Phase I/II Study of Intravenous Doxil and Intraperitoneal Carboplatin as Salvage Therapy in Patients With Recurrent Ovarian Cancer
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and carboplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving doxorubicin together with carboplatin may kill more tumor cells.
PURPOSE: This phase I and phase II trial is studying the side effects and best dose of
carboplatin when given together with doxorubicin to see how well it works in treating
patients with recurrent ovarian cancer.
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.
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