This is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of pertuzumab in combination with gemcitabine relative to placebo in combination with gemcitabine in subjects with advanced ovarian, primary peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
131
Placebo was provided as a single-use formulation for infusion.
Gemcitabine was provided as a solution for infusion.
Pertuzumab was provided as a single-use formulation for infusion.
Progression-free Survival
Progression-free survival was defined as the time from the first day of treatment (Cycle 1, Day 1) to the time of documented disease progression or death, whichever occurred first. Disease progression was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) was defined as \>=30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.
Time frame: Baseline to the end of the study (up to 1 year)
Percentage of Participants With an Objective Response
An objective response was defined as a complete or partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors (RECIST). A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.
Time frame: Baseline to the end of the study (up to 1 year)
Duration of the Objective Response
Duration of the objective response was defined as the time from the initial response to disease progression or death from any cause.
Time frame: Baseline to the end of the study (up to 1 year)
Percentage of Participants Free From Disease Progression at 4 Months
Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Baseline to Month 4
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Univ. of Alabama at Birmingham
Birmingham, Alabama, United States
Comprehensive Cancer Institute
Huntsville, Alabama, United States
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States
Arizona Cancer Center
Tucson, Arizona, United States
Alta Bates Comp. Cancer Ctr
Berkeley, California, United States
California Cancer Crae, Inc
Greenbrae, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Ventura County Hematology Oncology Specialists
Oxnard, California, United States
Sutter Cancer Center
Sacramento, California, United States
...and 31 more locations
Duration of Survival
Duration of survival was defined as the time from randomization until death from any cause.
Time frame: Baseline to the end of the study (up to 1 year)