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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.
 
ClinicalTrials.gov Identifier: NCT00098397
Recruitment Status : Completed
First Posted : December 8, 2004
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE December 7, 2004
First Posted Date  ICMJE December 8, 2004
Last Update Posted Date January 24, 2013
Study Start Date  ICMJE February 2005
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
  • 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 Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
Toxicity as measured by the standard WHO grading system [ Time Frame: Up to 14 months after completion of study treatment ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FR901228 in Treating Patients With Metastatic Breast Cancer
Official Title  ICMJE 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 Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
Intervention  ICMJE
  • Drug: romidepsin
    Given IV
    Other Names:
    • FK228
    • FR901228
    • Istodax
  • Other: laboratory biomarker analysis
    Optional correlative studies
Study Arms  ICMJE 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.
Interventions:
  • Drug: romidepsin
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2013)
37
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00098397
Other Study ID Numbers  ICMJE NCI-2012-02641
MDA-2003-0895
N01CM17003 ( U.S. NIH Grant/Contract )
CDR0000404163 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Massimo Cristofanilli M.D. Anderson Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date January 2013

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