A Phase II Evaluation Of Triapine (NCI-Supplied Agent: NSC #663249, IND #68338) In Combination With Cisplatin (Commercially Available: NSC # 119875) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma
I. Determine the antitumor activity of 3-AP and cisplatin in patients with recurrent or
persistent platinum-resistant ovarian epithelial or primary peritoneal cancer.
II. Determine the toxicity of this regimen in these patients.
I. Determine the duration of progression-free survival and overall survival in patients
treated with this regimen.
II. Determine the effects of prognostic variables, including initial performance status,
age, and mucinous (or clear cell) histology, in these patients.
OUTLINE: This is a non-randomized study.
Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and
3. Courses repeat every 21 days in the absence of disease progression or unacceptable
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 23-48 patients will be accrued for this study within 13
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Frequency and duration of objective response assessed using RECIST criteria
Up to 5 years
Gynecologic Oncology Group
United States: Food and Drug Administration
|Gynecologic Oncology Group||Philadelphia, Pennsylvania 19103|