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

NCT ID: NCT00085527

Last Updated: 2013-09-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2005-09-30

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.

Conditions

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

depsipeptide

Depsipeptide administered on Days 1, 8, and15 of a 28-day cycle.

Group Type: EXPERIMENTAL

depsipeptide

Intervention Type: DRUG

Interventions

depsipeptide

Intervention Type: DRUG

Other Intervention Names

Romidepsin, Istodax®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gini Fleming, MD

Role: STUDY_CHAIR

University of Chicago

Locations

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States

Countries

United States

Other Identifiers

UCCRC-12965

Identifier Type: -

Identifier Source: secondary_id

LUMC-106995

Identifier Type: -

Identifier Source: secondary_id

NCI-6347

Identifier Type: -

Identifier Source: secondary_id

12965A

Identifier Type: -

Identifier Source: org_study_id