Depsipeptide (Romidepsin) in Treating Patients With Recurrent Ovarian Epithelial or Peritoneal Cavity Cancer
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 Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Single Agent Depsipeptide (FK228) In Recurrent, Platinum Sensitive Adeno-Carcinoma Of The Ovary Or Peritoneum|
- Response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Estimated as proportion of patients with complete or partial reduction in tumor burden.
- Toxicity as assessed by CTCAE version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
- Time to progression [ Time Frame: From first treatment until the date of progression, assessed up to 5 years ] [ Designated as safety issue: No ]
- Survival [ Time Frame: From first treatment until death or the last date of contact, assessed up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2004|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
Experimental: Treatment (single-agent depsipeptide)
Patients receive depsipeptide (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091195
|United States, North Carolina|
|High Point Regional Hospital|
|High Point, North Carolina, United States, 27261|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Brigitte Miller||Wake Forest School of Medicine|