Primary Peritoneal Cavity Cancer Clinical Trial
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
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.
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