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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
Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


- Determine the response rate in patients with recurrent, platinum-sensitive ovarian
epithelial or peritoneal cavity cancer treated with FR901228 (depsipeptide).

- Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

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.

Patients are followed for 5 years.

PROJECTED ACCRUAL: A total of 22-51 patients will be accrued for this study.

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, CT scan, or 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



- Over 18

Performance status

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy

- More than 6 months


- WBC ≥ 3,000/mm^3

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

- Platelet count ≥ 100,000/mm^3


- Bilirubin normal

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


- Creatinine ≤ 1.5 times ULN OR

- 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


Biologic therapy

- 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

Endocrine therapy

- 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


- Not specified


- 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:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate as measured by physical exam and tumor measurements and radiologic examination at baseline, every 4 weeks for 12 weeks and after study completion (every 2 months for 1 year, every 3 months for 1 year and every 6 months for 3 years)

Safety Issue:


Principal Investigator

Brigitte E. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Federal Government

Study ID:




Start Date:

September 2004

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms