Phase II trial to study the effectiveness of ixabepilone in treating patients who have recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not responded to previous chemotherapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.
PRIMARY OBJECTIVES: I. Determine the antitumor activity of ixabepilone in patients with recurrent or persistent platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer. II. Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: Patients receive ixabepilone IV over 1 hour. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Given IV
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Tumor Response
Percentage of participants with complete and partial tumor response as assessed by the Gynecologic Oncology Group Response Evaluation Criteria in Solid Tumors (GOG RECIST) with one-sided 90% Confidence Interval. Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion, or a 50% decrease in the LD in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.
Time frame: Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months.
Number of People With Adverse Effects
Time frame: Every cycle until completion of study treatment up to 30 days after stopping study treatment
Progression Free Survival
Progression-Free Survival is the period from study entry until disease progression, death or date of last contact, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or a 50% increase in the LD taking as reference the smallest LD recorded since study entry in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression.
Time frame: From study entry to disease progression, death or date of last contact, whichever occurs first. Every other cycle, up to 5 years of follow-up
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Overall Survival
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Time frame: From study entry to death or last contact, up to 5 years of follow-up.