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FR901228 in Treating Patients With Relapsed or Refractory Advanced Ovarian Epithelial 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: NCT00085527
Recruitment Status : Withdrawn
First Posted : June 11, 2004
Last Update Posted : September 5, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago

Brief Summary:

RATIONALE: FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with relapsed or refractory advanced ovarian epithelial cancer.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: depsipeptide Phase 2

Detailed Description:



  • Determine the response rate (complete and partial) in patients with relapsed or refractory advanced ovarian epithelial carcinoma treated with FR901228 (depsipeptide).
  • Determine the toxicity of this drug in these patients.


  • Correlate clinical response with platinum sensitivity in patients treated with this drug.
  • Correlate clinical response with P-glycoprotein expression or p53 status in patients treated with this drug.

OUTLINE: This is multicenter study. Patients are stratified according to response to prior platinum administration (platinum resistant vs platinum sensitive).

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 20-37 patients will be accrued for this study within 12 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Depsipeptide In Patients With Relapsed Or Refractory Ovarian Carcinoma
Study Start Date : May 2005
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Romidepsin

Arm Intervention/treatment
Experimental: depsipeptide
Depsipeptide administered on Days 1, 8, and15 of a 28-day cycle.
Drug: depsipeptide
Other Name: Romidepsin, Istodax®

Primary Outcome Measures :
  1. Response rate of depsipeptide in ovarian cancer [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed ovarian epithelial carcinoma

    • Advanced disease
  • Relapsed after OR refractory to 1, and only 1, prior platinum- or taxane-based regimen

    • Refractory disease defined as disease progression during platinum- or taxane-based therapy
    • Relapsed disease defined as platinum or taxane resistant or sensitive

      • Platinum or taxane resistance defined as relapse within 6 months after prior platinum or taxane therapy
      • Platinum or taxane sensitivity defined as relapse > 6 months from the last platinum or taxane treatment
  • Measurable or evaluable disease

    • Measurable disease defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
    • Evaluable disease determined by elevation in CA 125 (≥ 2 times upper limit of normal [ULN]), ascites, or pleural effusion
  • No known brain metastases



  • 18 and over

Performance status

  • SWOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • At least 24 weeks


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • WBC ≥ 3,000/mm^3


  • AST and ALT ≤ 2.5 times ULN
  • Bilirubin normal


  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min


  • QTc < 500 msec
  • LVEF > 40% by MUGA
  • No significant cardiac disease
  • No symptomatic congestive heart failure
  • No unstable or poorly controlled angina pectoris
  • No uncontrolled dysrhythmias
  • No New York Heart Association class III or IV congestive heart failure
  • No myocardial infarction within the past year
  • No prior serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
  • No left ventricular hypertrophy by EKG


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Potassium ≥ 4.0 mmol/L
  • Magnesium ≥ 2.0 mg/dL
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to FR901228 (depsipeptide)
  • No concurrent uncontrolled illness
  • No active or ongoing infection
  • No psychiatric illness or social situation that would preclude study compliance


Biologic therapy

  • No concurrent biologic agents


  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior FR901228 (depsipeptide)
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified


  • More than 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy


  • Prior surgical resection allowed


  • No concurrent drugs known to have HDI activity (e.g., sodium valproate)
  • No concurrent agents that cause QTc prolongation
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent hydrochlorothiazide
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy

Information from the National Library of Medicine

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 identifier (NCT number): NCT00085527

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United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)
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Study Chair: Gini Fleming, MD University of Chicago
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Responsible Party: University of Chicago Identifier: NCT00085527    
Other Study ID Numbers: 12965A
First Posted: June 11, 2004    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013
Keywords provided by University of Chicago:
recurrent ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
Additional relevant MeSH terms:
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Carcinoma, Ovarian Epithelial
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antibiotics, Antineoplastic
Antineoplastic Agents