Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
791
Bevacizumab 10 mg/kg intravenous (IV) q8wks
Temsirolimus 25 mg IV weekly
Bevacizumab 10 mg/kg intravenous (IV) q8wks
Progression-Free Survival (PFS): Independent-Assessment
PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
Time frame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Progression-Free Survival (PFS): Investigator-Assessment
PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by investigator imaging reviewers using RECIST criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
Time frame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Time frame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Overall Survival (OS)
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Interferon-Alfa 9MU SC TIW
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, United States
South County Hematology/Oncology
Chula Vista, California, United States
Cancer Center Oncology Medical Group
La Mesa, California, United States
UCLA Medical Center
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
North County Oncology Medical Clinic
Oceanside, California, United States
Medical Oncology Associates - SD
San Diego, California, United States
Sharp Memorial Hospital Investigational Pharmacy
San Diego, California, United States
Sharp Rees-Stealy
San Diego, California, United States
...and 162 more locations
OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time frame: Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)