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

Primary Purpose

Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
romidepsin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Peritoneal Cavity Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • High Point Regional Hospital
  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (single-agent depsipeptide)

Arm Description

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.

Outcomes

Primary Outcome Measures

Response rate
Estimated as proportion of patients with complete or partial reduction in tumor burden.
Toxicity as assessed by CTCAE version 3.0
Time to progression
Survival

Secondary Outcome Measures

Full Information

First Posted
September 7, 2004
Last Updated
March 18, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00091195
Brief Title
Depsipeptide (Romidepsin) in Treating Patients With Recurrent Ovarian Epithelial or Peritoneal Cavity Cancer
Official Title
A Phase II Study Of Single Agent Depsipeptide (FK228) In Recurrent, Platinum Sensitive Adeno-Carcinoma Of The Ovary Or Peritoneum
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
September 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (single-agent depsipeptide)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
romidepsin
Other Intervention Name(s)
FK228, FR901228, Istodax
Primary Outcome Measure Information:
Title
Response rate
Description
Estimated as proportion of patients with complete or partial reduction in tumor burden.
Time Frame
Up to 5 years
Title
Toxicity as assessed by CTCAE version 3.0
Time Frame
Up to 5 years
Title
Time to progression
Time Frame
From first treatment until the date of progression, assessed up to 5 years
Title
Survival
Time Frame
From first treatment until death or the last date of contact, assessed up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte Miller
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
High Point Regional Hospital
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27261
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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