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A Phase II Study Of Single Agent Depsipeptide (FK228) In Recurrent, Platinum Sensitive Adeno-Carcinoma Of The Ovary Or Peritoneum

Phase 2
18 Years
Not Enrolling
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Thank you

Trial Information

A Phase II Study Of Single Agent Depsipeptide (FK228) In Recurrent, Platinum Sensitive Adeno-Carcinoma Of The Ovary Or Peritoneum


I. To estimate the response rate of recurrent, platinum-sensitive adenocarcinoma of the
ovarian or peritoneal to depsipeptide (romidepsin).

II. To determine the toxicity of depsipeptide in this patient population.

OUTLINE: This is a multicenter study.

Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and
15. Courses repeat every 28 days in the absence of disease progression or unacceptable

Patients are followed up for 5 years.

Inclusion Criteria:

- Histologically or cytologically confirmed primary ovarian epithelial or peritoneal
cavity cancer

- Histologic confirmation of recurrent disease not required

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques (including palpation, plain x-ray, computed tomography [CT]
scan, or magnetic resonance imaging [MRI]) OR ≥ 10 mm by spiral CT scan

- Achieved a complete response after initial prior platinum-containing (cisplatin or
carboplatin) chemotherapy regimen (e.g., conventional-dose therapy, high-dose
therapy, consolidation therapy, or extended therapy after surgical or nonsurgical

- Patients who have not received paclitaxel or docetaxel as initial therapy may
receive a second regimen containing these drugs

- No prior chemotherapy for persistent or recurrent disease, including
re-treatment with the original regimen

- Platinum-sensitive disease, defined as having a treatment-free interval with no
evidence of progressive disease for > 6 but < 12 months after completion of a
platinum-based regimen

- No known brain metastases

- Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2

- Performance status - Karnofsky 60-100%

- More than 6 months

- White blood cells (WBC) ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin normal

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper
limit of normal (ULN)

- Creatinine ≤ 1.5 times ULN

- Creatinine clearance ≥ 60 mL/min

- No New York Heart Association class III or IV congestive heart failure

- No myocardial infarction within the past year

- No uncontrolled dysrhythmias

- No poorly controlled angina

- No history of serious ventricular arrhythmia (e.g., ventricular tachycardia or
ventricular fibrillation, ≥ 3 beats in a row)

- QTc interval < 500 msec

- No other significant cardiac disease

- Potassium normal

- Magnesium normal

- No uncontrolled electrolyte abnormality (hypokalemia and hypomagnesemia)

- No ongoing or active infection requiring antibiotics

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to study drug

- No neuropathy ≥ grade 2

- No other uncontrolled illness

- No psychiatric illness or social situation that would preclude study compliance

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior monoclonal antibodies, cytokines, or signal transduction inhibitors for
recurrent disease

- No concurrent biologic therapy

- See Disease Characteristics

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
for the primary malignancy

- No prior FR901228 (depsipeptide)

- No other concurrent chemotherapy

- More than 4 weeks since prior hormonal therapy for the primary malignancy

- Concurrent estrogen replacement therapy allowed

- More than 4 weeks since prior radiotherapy

- No prior radiotherapy to > 25% of bone marrow

- No concurrent radiotherapy

- Recovered from all prior therapy

- More than 4 weeks since prior noncytotoxic therapy for the primary malignancy

- No other prior noncytotoxic therapy for recurrent disease

- No concurrent combination anti-retroviral therapy for HIV-positive patients

- No other concurrent drugs known to have histone deacetylase inhibitor activity (e.g.,
valproic acid)

- No concurrent agents that cause QTc prolongation

- No other concurrent investigational agents

- No other concurrent anticancer agents

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

Estimated as proportion of patients with complete or partial reduction in tumor burden.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Brigitte Miller

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University


United States: Food and Drug Administration

Study ID:




Start Date:

September 2004

Completion Date:

Related Keywords:

  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms



High Point Regional Hospital High Point, North Carolina  27261
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157