FR901228 in Treating Patients With Relapsed or Refractory Advanced Ovarian Epithelial Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00085527
First received: June 10, 2004
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Ovarian Cancer
Drug: depsipeptide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Depsipeptide In Patients With Relapsed Or Refractory Ovarian Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Response rate of depsipeptide in ovarian cancer [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: depsipeptide
Depsipeptide administered on Days 1, 8, and15 of a 28-day cycle.
Drug: depsipeptide
Other Name: Romidepsin, Istodax®

Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • SWOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • At least 24 weeks

Hematopoietic

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

Hepatic

  • AST and ALT ≤ 2.5 times ULN
  • Bilirubin normal

Renal

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

Cardiovascular

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent biologic agents

Chemotherapy

  • 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

Radiotherapy

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

Surgery

  • Prior surgical resection allowed

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085527

Locations
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Gini Fleming, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00085527     History of Changes
Other Study ID Numbers: 12965A, UCCRC-12965, LUMC-106995, NCI-6347
Study First Received: June 10, 2004
Last Updated: September 4, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by University of Chicago:
recurrent ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Romidepsin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014