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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
High Point Regional Hospital
High Point, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Response rate
Estimated as proportion of patients with complete or partial reduction in tumor burden.
Time frame: Up to 5 years
Toxicity as assessed by CTCAE version 3.0
Time frame: Up to 5 years
Time to progression
Time frame: From first treatment until the date of progression, assessed up to 5 years
Survival
Time frame: From first treatment until death or the last date of contact, assessed up to 5 years
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