The purpose of this study is to evaluate the effectiveness and tolerability of the combination of bevacizumab and Abraxane in the treatment of women with epithelial ovarian cancer or peritoneal cancer. The study will also evaluate how the patient's quality of life is during their treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Bevacizumab will be given via IV infusion at 10mg/kg given on days 1 and 15 of a 28-day cycle.
Abraxane will be given via IV infusion at 100mg/m²over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
Little Rock Hematology Oncology
Little Rock, Arkansas, United States
Wilshire Oncology Medical Group, Inc.
La Verne, California, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States
6-month Progression-Free Rate
Progression-free rate is defined as the percentage of participants with no progression event at 6 months after starting study treatment. An event for this endpoint was defined as a progression-free survival event occurring earlier than six months, or discontinuation of treatment earlier than six months for any other reason. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.
Time frame: 6 months after initiation of study treatment
Best Overall Response
Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR.
Time frame: Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months.
Overall Survival
Time frame: Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months.
Progression-free Survival (PFS)
Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.
Time frame: PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first, assessed up to 30 months.
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Southeastern Gynecologic Oncology, LLC
Atlanta, Georgia, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States
Hematology-Oncology Centers of the Northern Rockies
Billings, Montana, United States
Mid-Ohio Oncology/Hematology
Columbus, Ohio, United States
Pennsylvania Oncology Hematology Assoc.
Philadelphia, Pennsylvania, United States
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee, United States
The West Clinic
Memphis, Tennessee, United States
...and 1 more locations
Best Overall Response at Six Months
The outcome measure assessed the percentage of participants who had achieved either a Partial or Complete Response over 6 months of treatment. Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR.
Time frame: Assessed over 6 months of study treatment