Depsipeptide (Romidepsin) in Treating Patients With Recurrent Ovarian Epithelial or Peritoneal Cavity Cancer
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|