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

Primary Purpose

Ovarian Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
depsipeptide
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

depsipeptide

Arm Description

Depsipeptide administered on Days 1, 8, and15 of a 28-day cycle.

Outcomes

Primary Outcome Measures

Response rate of depsipeptide in ovarian cancer

Secondary Outcome Measures

Full Information

First Posted
June 10, 2004
Last Updated
September 4, 2013
Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00085527
Brief Title
FR901228 in Treating Patients With Relapsed or Refractory Advanced Ovarian Epithelial Cancer
Official Title
A Phase II Study Of Depsipeptide In Patients With Relapsed Or Refractory Ovarian Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Withdrawn
Study Start Date
May 2005 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
depsipeptide
Arm Type
Experimental
Arm Description
Depsipeptide administered on Days 1, 8, and15 of a 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
depsipeptide
Other Intervention Name(s)
Romidepsin, Istodax®
Primary Outcome Measure Information:
Title
Response rate of depsipeptide in ovarian cancer
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gini Fleming, MD
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
Cardinal Bernardin Cancer Center at Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

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

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