Phase II trial to study the effectiveness of CT-2103 in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PRIMARY OBJECTIVES: I. Determine the antitumor activity of polyglutamate paclitaxel (CT-2103) as third-line treatment for patients with recurrent or persistent ovarian epithelial or primary peritoneal cancer. II. Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive polyglutamate paclitaxel (CT-2103) IV over 10-20 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Given IV
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Frequency and duration of objective response
Time frame: 5 years
Frequency and severity of observed adverse effects
Time frame: 5 years
Survival time
Time frame: 5 years
Duration of progression-free interval
Time frame: 5 years
Change in objective response
Time frame: Baseline to 5 years
Change in observed adverse effects
Time frame: Baseline to 5 years
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