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Vorinostat in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cavity Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00132067
First Posted: August 19, 2005
Last Update Posted: June 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  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. 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.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Vorinostat, (SAHA, NCI-Supplied Agent [NSC #701852]) 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 survival (PFS) [ Time Frame: At 6 months ]
    Time at risk will be assessed from the date of registration onto the study and include all eligible patients who receive any study treatment. An analysis of any potential treatment effect on PFS may be conducted against the historical controls provided in GOG 126 and GOG 146 using a proportional hazards model that includes histological cell type, performance status, and platinum sensitivity.

  • Toxicity as assessed by CTCAE v 3.0 [ Time Frame: Up to 5 years after completion of study treatment ]

Secondary Outcome Measures:
  • Clinical response (partial and complete response) rate as according to RECIST s [ Time Frame: Up to 5 years ]
  • Duration of PFS [ Time Frame: From study entry until disease progression, death or date of last contact., assessed up to 5 years ]
  • Duration of survival [ Time Frame: From entry into the study to death or the date of last contact, assessed up to 5 years ]

Enrollment: 60
Study Start Date: October 2005
Study Completion Date: July 2008
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (vorinostat)
Patients receive oral vorinostat twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: vorinostat
Given orally
Other Names:
  • L-001079038
  • SAHA
  • suberoylanilide hydroxamic acid
  • Zolinza

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the 6-month progression-free survival rate in patients with recurrent or persistent ovarian epithelial or primary peritoneal cavity cancer treated with vorinostat.

II. Determine the toxicity of this drug, in terms of the frequency and severity of adverse reactions in these patients.

SECONDARY OBJECTIVES:

I. Determine the clinical response rate (partial response and complete response) in patients treated with this drug.

II. Determine the duration of progression-free survival and overall survival of patients treated with this drug.

III. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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
  • Performance status - GOG 0-1
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Able to take oral medication
  • No bowel obstruction
  • No persistent vomiting
  • No parenteral feeding
  • 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
  • At least 4 weeks since prior immunotherapy for the malignancy
  • 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
  • At least 1 week since prior hormonal therapy for the malignancy
  • Concurrent hormone replacement therapy allowed
  • At least 4 weeks since prior radiotherapy for the malignancy and recovered
  • No prior radiotherapy to > 25% of bone marrow
  • At least 4 weeks since prior surgery for the malignancy and recovered
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132067


Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Susan Modesitt Gynecologic Oncology Group
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00132067     History of Changes
Other Study ID Numbers: NCI-2012-02667
NCI-2012-02667 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG 0170H
CDR0000439489
GOG-0170H ( Other Identifier: Gynecologic Oncology Group )
GOG-0170H ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: August 16, 2005
First Posted: August 19, 2005
Last Update Posted: June 12, 2014
Last Verified: January 2013

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Peritoneal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Vorinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action