Primary Peritoneal Cavity Cancer Clinical Trial
Official title:
A Phase II Study Of Single Agent Depsipeptide (FK228) In Recurrent, Platinum Sensitive Adeno-Carcinoma Of The Ovary Or Peritoneum
This phase II trial is studying how well depsipeptide (romidepsin) works in treating patients with recurrent ovarian epithelial or peritoneal cavity cancer. Drugs used in chemotherapy, such as depsipeptide (romidepsin), work in different ways to stop tumor cells from dividing so they stop growing or die. Depsipeptide (romidepsin) may also stop the growth of ovarian epithelial or peritoneal cavity cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth
PRIMARY OBJECTIVES:
I. To estimate the response rate of recurrent, platinum-sensitive adenocarcinoma of the
ovarian or peritoneal to depsipeptide (romidepsin).
II. To determine the toxicity of depsipeptide in this patient population.
OUTLINE: This is a multicenter study.
Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and
15. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity.
Patients are followed up for 5 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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