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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00085527
• Other study ID #: 12965A
• Secondary ID: UCCRC-12965LUMC-
• Status: Withdrawn
• Phase: Phase 2
• First received: June 10, 2004
• Last updated: September 4, 2013
• Start date: May 2005
• Est. completion date: September 2005

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• depsipeptide

Locations

Country	Name	City	State
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate of depsipeptide in ovarian cancer		8 weeks	No