Depsipeptide (Romidepsin) in Treating Patients With Recurrent Ovarian Epithelial or Peritoneal Cavity Cancer

Study Overview
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Brief Summary
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This phase II trial is studying how well depsipeptide (romidepsin) works in treating patients with recurrent ovarian epithelial or peritoneal cavity cancer. Drugs used in chemotherapy, such as depsipeptide (romidepsin), work in different ways to stop tumor cells from dividing so they stop growing or die. Depsipeptide (romidepsin) may also stop the growth of ovarian epithelial or peritoneal cavity cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth

Detailed Description
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PRIMARY OBJECTIVES: 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 toxicity. Patients are followed up for 5 years.

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

Conditions
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Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Intervention / Treatment
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* Drug: romidepsin


Participation Criteria
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Eligibility Criteria
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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 assessment) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (single-agent depsipeptide)<br>Patients receive depsipeptide (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | Drug: romidepsin<br> <br> * Other names: Istodax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Estimated as proportion of patients with complete or partial reduction in tumor burden. | Up to 5 years | 
| Toxicity as assessed by CTCAE version 3.0 |  | Up to 5 years | 
| Time to progression |  | From first treatment until the date of progression, assessed up to 5 years | 
| Survival |  | From first treatment until death or the last date of contact, assessed up to 5 years |