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Vorinostat in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cavity Cancer
This study has been completed.
First Received: August 16, 2005   Last Updated: August 6, 2008   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00132067
  Purpose

RATIONALE: Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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


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

Study Type: Interventional
Study Design: Treatment, Non-Randomized
Official Title: A Phase II Evaluation of Vorinostat, (SAHA, NCI-Supplied Agent [NSC #701852, IND #71976]) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-free at 6 months [ Designated as safety issue: No ]
  • Toxicity as measured by CTCAE v 3.0 at every course [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical response rate as measured by RECIST criteria after every 2 courses [ Designated as safety issue: No ]
  • Duration of progression-free and overall survival [ Designated as safety issue: No ]

Study Start Date: July 2005
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the 6-month progression-free survival rate in patients with recurrent or persistent ovarian epithelial or primary peritoneal cavity cancer treated with vorinostat.
  • Determine the toxicity of this drug, in terms of the frequency and severity of adverse reactions in these patients.

Secondary

  • Determine the clinical response rate (partial response and complete response) in patients treated with this drug.
  • Determine the duration of progression-free survival and overall survival of patients treated with this drug.
  • Determine the impact of prognostic variables (e.g., platinum sensitivity, performance status, and cellular histology) in patients treated with this drug.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive oral vorinostat twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within approximately 1 year.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer
  • Recurrent or persistent disease

    • Disease progression during OR persistent disease after completion of 1 prior platinum-based chemotherapy regimen (containing carboplatin, cisplatin, or other organoplatinum compound) for primary disease

      • Initial treatment may have included high-dose, consolidation, noncytotoxic agents, or extended therapy administered after surgical or non-surgical assessment
      • Treatment-free interval after completion of platinum-based chemotherapy must have been < 12 months
  • Measurable disease, defined as ≥ 1 unidimensionally measurable target* lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan NOTE: *Tumors within a previously irradiated field are not considered target lesions unless there has been subsequent disease progression at least 90 days after prior radiotherapy
  • Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-1

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Gastrointestinal

  • Able to take oral medication
  • No bowel obstruction
  • No persistent vomiting
  • No parenteral feeding

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
  • No neuropathy (sensory and motor) > grade 1
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No active infection requiring antibiotics
  • No psychiatric illness or social situation that would preclude study compliance
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to vorinostat
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior immunotherapy for the malignancy

Chemotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) for the malignancy and recovered
  • No more than 2 prior cytotoxic chemotherapy regimens for recurrent or persistent disease
  • No prior non-cytotoxic chemotherapy for recurrent or persistent disease, unless therapy was part of the primary treatment regimen
  • No prior vorinostat

Endocrine therapy

  • At least 1 week since prior hormonal therapy for the malignancy
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy for the malignancy and recovered
  • No prior radiotherapy to > 25% of bone marrow

Surgery

  • At least 4 weeks since prior surgery for the malignancy and recovered

Other

  • At least 4 weeks since other prior therapy for the malignancy
  • At least 30 days since prior and no concurrent valproic acid
  • Concurrent oral anticoagulants (i.e., warfarin) allowed provided there is increased vigilance with respect to monitoring PT/INR for the first 2 courses of study therapy or if there are any signs of bleeding
  • No prior anticancer therapy that would preclude study participation
  • No concurrent combination anti-retroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00132067

Locations
United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
United States, Connecticut
New Britain General Hospital
New Britain, Connecticut, United States, 06050
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Indiana
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0293
United States, Maryland
Union Hospital Cancer Center at Union Hospital
Elkton MD, Maryland, United States, 21921
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
United States, Nebraska
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114
United States, New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Voorhees, New Jersey, United States, 08043
Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital
Teaneck, New Jersey, United States, 07666
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Susan C. Modesitt, MD Lucille P. Markey Cancer Center at University of Kentucky
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000439489, GOG-0170H
Study First Received: August 16, 2005
Last Updated: August 6, 2008
ClinicalTrials.gov Identifier: NCT00132067     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Anticarcinogenic Agents
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Peritoneal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Vorinostat
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Abdominal Neoplasms
Protective Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Digestive System Diseases
Analgesics, Non-Narcotic
Peritoneal Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010