Expired Study
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Maywood, Illinois 60153


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.


Study summary:

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.


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


NCT ID:

NCT00085527


Primary Contact:

Study Chair
Gini Fleming, MD
University of Chicago


Backup Contact:

N/A


Location Contact:

Maywood, Illinois 60153
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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