This phase II trial is studying the side effects and how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PRIMARY OBJECTIVES: I. Determine the antitumor activity of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®), in terms of frequency and duration of objective response, in patients with persistent or recurrent platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cancer. II. Determine the toxicity of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the duration of progression-free survival and overall survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®) IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Colorado Gynecologic Oncology Group
Aurora, Colorado, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Rush University Medical Center
Chicago, Illinois, United States
Union Hospital of Cecil County
Elkton, Maryland, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
North Shore University Hospital
Manhasset, New York, United States
North Shore-LIJ Health System CCOP
Manhasset, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
...and 10 more locations
Tumor Response
Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; 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. CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.
Time frame: every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels
Frequency and Severity of Observed Adverse Effects
Time frame: Every cycle during treatment and up to 5 years after completion of treatment
Progression-free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.
Time frame: from study entry until disease progression, death or date of last contact.
Overall Survival
Time frame: from entry into the study to death or the date of last contact.
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