Clinical trial · Interventional
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
NCT00085527CI-TRIAL-00012010withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| depsipeptide | Drug | Romidepsin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- depsipeptide
- description
- Depsipeptide administered on Days 1, 8, and15 of a 28-day cycle.
- interventionNames
- Drug: depsipeptide
Primary outcomes (1)
- measure
- Response rate of depsipeptide in ovarian cancer
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.