This is a Phase III, multicenter, placebo-controlled, double-blind, randomized study. Approximately 650 patients will be randomized in a 1:1 ratio to one of two treatment arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
636
intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
oral erlotinib HCl 150 mg/day orally
intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
Kaiser Permanente - Vallejo
Vallejo, California, United States
University Cancer & Blood Center, LLC; Research
Athens, Georgia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Anne Arundel Health System Research Instit-Annapolis Oncology Ctr
Annapolis, Maryland, United States
Overall Survival (OS) Among All Randomized Patients
Overall Survival was defined as the period from the date of randomization until the date of patient death from any cause. For patients who had not died, survival data was censored at the date of last contact.
Time frame: From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years)
Progression-free Survival (PFS)
PFS was defined as the time from randomization to documented disease progression, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST), or death on study treatment, whichever occurred first.
Time frame: From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years)
Percentage of Participants With Objective Response
Objective response was defined as a complete or partial response determined by RECIST on two consecutive occasions \>= 4 weeks apart.
Time frame: The median duration of Objective response was up to 9.7 months
Duration of Objective Response
Duration of objective response was defined as the period from the date of the initial partial or complete response until the date of disease progression or death on study treatment from any cause. For patients who had not died, data was censored at the date of last contact.
Time frame: Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months)
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