Clinical Trial: FR901228 in Treating Patients With Metastatic Breast Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Study Of Single Agent Depsipeptide (FK228) In Breast Cancer
Brief Summary: This phase II trial is studying how well FR901228 works in treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as FR901228, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. FR901228 may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Summary:
PRIMARY OBJECTIVES:
I. Determine the efficacy and safety of FR901228 (depsipeptide) in patients with metastatic breast cancer.
SECONDARY OBJECTIVES:
I. Determine the clinical activity of this drug, in terms of progression-free survival, in these patients.
OUTLINE: This is a multicenter study.
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2.4-12.3 months.
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome:
- Efficacy (complete and partial response) according to RECIST [ Time Frame: Up to 14 months ]
- Progression-free survival [ Time Frame: From the first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 14 months ]
Original Primary Outcome:
Current Secondary Outcome: Toxicity as measured by the standard WHO grading system [ Time Frame: Up to 14 months after completion of study treatment ]
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: December 7, 2004
Date Started: February 2005
Date Completion:
Last Updated: January 23, 2013
Last Verified: January 2013
