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

A Phase II Study Of Depsipeptide In Patients With Relapsed Or Refractory Ovarian Carcinoma

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00085527
Enrollment
0
Registered
2004-06-11
Start date
2005-05-31
Completion date
2005-09-30
Last updated
2013-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer

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.

Interventions

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Chicago
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Response rate of depsipeptide in ovarian cancer8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026