A Phase II Study Of Depsipeptide In Patients With Relapsed Or Refractory Ovarian Carcinoma
depsipeptide
Carcinoma, Ovarian Epithelial+16
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: May 1, 2005
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, United StatesOpen Cardinal Bernardin Cancer Center at Loyola University Medical Center in Google Maps