Depsipeptide (Romidepsin) in Treating Patients With Recurrent Ovarian Epithelial or Peritoneal Cavity Cancer
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|ClinicalTrials.gov Identifier: NCT00091195|
Recruitment Status : Terminated (Administratively complete.)
First Posted : September 9, 2004
Last Update Posted : March 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer||Drug: romidepsin||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Single Agent Depsipeptide (FK228) In Recurrent, Platinum Sensitive Adeno-Carcinoma Of The Ovary Or Peritoneum|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||March 2007|
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.
- Response rate [ Time Frame: Up to 5 years ]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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 University Health Sciences|