Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. This phase II trial is studying how well giving 3-AP together with cisplatin works in treating patients with recurrent or persistent platinum-resistant ovarian epithelial cancer or primary peritoneal cancer
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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 toxicity. Patients are followed for 5 years. PROJECTED ACCRUAL: A total of 23-48 patients will be accrued for this study within 13 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Frequency and duration of objective response assessed using RECIST criteria
Time frame: Up to 5 years
Frequency and severity of observed adverse effects assessed using CTCAE version 3.0
Time frame: Up to 5 years
Duration of progression-free survival
Time frame: From study entry until disease recurrence, death or date of last contact, assessed up to 5 years
Duration of overall survival
Time frame: From study entry to death or date of last contact, assessed up to 5 years
Prognostic variables (e.g., initial performance status, age, and mucinous [or clear cell] histology)
Time frame: Up to 5 years
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