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

• Status: Withdrawn
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: National Cancer Institute (NCI)
• Treatments: Romidepsin

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