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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate of depsipeptide in ovarian cancer

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Gini Fleming, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

12965A

NCT ID:

NCT00085527

Start Date:

May 2005

Completion Date:

September 2005

Related Keywords:

  • Ovarian Cancer
  • recurrent ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500