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

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00091195
First received: September 7, 2004
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Drug: romidepsin
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Single Agent Depsipeptide (FK228) In Recurrent, Platinum Sensitive Adeno-Carcinoma Of The Ovary Or Peritoneum

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Estimated as proportion of patients with complete or partial reduction in tumor burden.

  • Toxicity as assessed by CTCAE version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Time to progression [ Time Frame: From first treatment until the date of progression, assessed up to 5 years ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: From first treatment until death or the last date of contact, assessed up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: September 2004
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (single-agent depsipeptide)
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
Other Names:
  • FK228
  • FR901228
  • Istodax

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091195

Locations
United States, North Carolina
High Point Regional Hospital
High Point, North Carolina, United States, 27261
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Investigators
Principal Investigator: Brigitte Miller Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00091195     History of Changes
Obsolete Identifiers: NCT01645670, NCT01660282
Other Study ID Numbers: NCI-2012-01036, CCCWFU 83403, U10CA081851
Study First Received: September 7, 2004
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Romidepsin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014