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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Given orally
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Progression-free survival (PFS)
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.
Time frame: At 6 months
Toxicity as assessed by CTCAE v 3.0
Time frame: Up to 5 years after completion of study treatment
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
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