Status:
WITHDRAWN
FR901228 in Treating Patients With Relapsed or Refractory Advanced Ovarian Epithelial Cancer
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 r...
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). * Determi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00085527
Start Date
May 1 2005
End Date
September 1 2005
Last Update
September 5 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153