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FR901228 in Treating Patients With Recurrent Ovarian Epithelial or Peritoneal Cavity Cancer
This study has been completed.
First Received: September 7, 2004   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Wake Forest University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00091195
  Purpose

RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop tumor cells from dividing so they stop growing or die. FR901228 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.

PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with recurrent ovarian epithelial or peritoneal cavity cancer.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: romidepsin
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: FR 901228
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of Single Agent Depsipeptide (FK228) In Recurrent, Platinum Sensitive Adeno-Carcinoma Of The Ovary Or Peritoneum

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

Primary Outcome Measures:
  • 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) [ Designated as safety issue: No ]
  • Toxicity as measured by physical exam and adverse event (AE) evaluation 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) (AE evaluation only) [ Designated as safety issue: Yes ]

Study Start Date: September 2004
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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 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

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 6 months

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

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

Renal

  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior monoclonal antibodies, cytokines, or signal transduction inhibitors for recurrent disease
  • No concurrent biologic therapy

Chemotherapy

  • 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

Radiotherapy

  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to > 25% of bone marrow
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

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

Locations
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1030
High Point Regional Hospital
High Point, North Carolina, United States, 27262
Sponsors and Collaborators
Wake Forest University
Investigators
Study Chair: Brigitte E. Miller, MD Wake Forest University
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000384614, CCCWFU-83403, NCI-6321
Study First Received: September 7, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00091195     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Romidepsin
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian Epithelial Cancer
Abdominal Neoplasms
Recurrence
Carcinoma
Genital Diseases, Female
Anti-Bacterial Agents
Digestive System Diseases
Peritoneal Diseases
Ovarian Cancer
Gastrointestinal Neoplasms
Endocrinopathy
Peritoneal Neoplasms
Adenocarcinoma
Endocrine Gland Neoplasms

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

ClinicalTrials.gov processed this record on May 06, 2009