FR901228 in Treating Patients With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00098397
Recruitment Status : Completed
First Posted : December 8, 2004
Last Update Posted : January 24, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

December 7, 2004
December 8, 2004
January 24, 2013
February 2005
September 2005   (Final data collection date for primary outcome measure)
  • 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 ]
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Complete list of historical versions of study NCT00098397 on Archive Site
Toxicity as measured by the standard WHO grading system [ Time Frame: Up to 14 months after completion of study treatment ]
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FR901228 in Treating Patients With Metastatic Breast Cancer
A Phase II Study Of Single Agent Depsipeptide (FK228) In Breast Cancer
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


I. Determine the efficacy and safety of FR901228 (depsipeptide) in patients with metastatic breast cancer.


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.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Drug: romidepsin
    Given IV
    Other Names:
    • FK228
    • FR901228
    • Istodax
  • Other: laboratory biomarker analysis
    Optional correlative studies
Experimental: Treatment (romidepsin)
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.
  • Drug: romidepsin
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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September 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed breast cancer

    • Metastatic disease
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
    • The following are not considered measurable disease:

      • Bone disease only
      • Pleural effusion
      • Peritoneal effusion
  • Must have received prior anthracycline (doxorubicin or epirubicin) and/or taxane (paclitaxel or docetaxel) as adjuvant therapy or for advanced disease

    • Therapy with high-dose regimens or bone marrow transplantation is considered 1 prior regimen
  • No known brain metastases
  • Hormone receptor status:

    • Not specified
  • Male or female
  • Performance status - ECOG 0-1
  • Performance status - Karnofsky 70-100%
  • More than 12 weeks
  • Absolute neutrophil count ≥ 1,500/mm^3
  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin normal
  • AST or ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal
  • Creatinine clearance ≥ 60 mL/min
  • QTc < 500 msec
  • No New York Heart Association class III or IV congestive heart failure
  • No myocardial infarction within the past year
  • No uncontrolled dysrhythmia
  • No poorly controlled angina
  • No other significant cardiac disease
  • No history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to FR901228
  • No active or ongoing infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No concurrent biologic agents
  • No more than 1 prior chemotherapy regimen for metastatic disease
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior FR901228 (depsipeptide)
  • No other concurrent chemotherapy
  • Prior hormonal therapy for metastatic disease or as adjuvant therapy allowed
  • More than 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy
  • More than 2 weeks since prior minor surgery and recovered
  • More than 4 weeks since prior major surgery and recovered
  • Concurrent bisphosphonates allowed provided therapy was initiated ≥ 3 months ago
  • No concurrent agents that cause QTc prolongation
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent drugs known to have histone deacetylase activity (e.g., valproic acid)
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
N01CM17003 ( U.S. NIH Grant/Contract )
CDR0000404163 ( Registry Identifier: PDQ (Physician Data Query) )
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National Cancer Institute (NCI)
National Cancer Institute (NCI)
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Principal Investigator: Massimo Cristofanilli M.D. Anderson Cancer Center
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP