A Phase II Study Of Single Agent Depsipeptide (FK228) In Recurrent, Platinum Sensitive Adeno-Carcinoma Of The Ovary Or Peritoneum
romidepsin
Carcinoma, Ovarian Epithelial+16
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: September 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.51 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
High Point Regional Hospital
High Point, United StatesOpen High Point Regional Hospital in Google MapsWake Forest University Health Sciences
Winston-Salem, United States