The purpose of this study is to see if higher dose of bevacizumab can be taken safely by some patients and if changes in the dose of bevacizumab have any effect on blood pressure.
Carboplatin and pemetrexed are FDA approved chemotherapy agents for patients with advanced non squamous non small cell lung cancer. Bevacizumab is also FDA approved in lung cancer , and the combination of all three drugs is promising. The doctors directing this research want to learn how to better personalize drug dosing of bevacizumab by identifying people who could safely take a higher dose of the drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Pemetrexed 500 mg/m\^2 intravenously over 10 minutes
Carboplatin at a dose calculated to produce an area under the concentration-time curve of 6 mg/ml•min intravenously over 30 minutes
Bevacizumab at 7.5 mg/kg intravenously over 90 minutes
The University of Chicago Medical Center
Chicago, Illinois, United States
North Shore University Health System
Evanston, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Change in 24 Hour Diastolic Blood Pressure (DBP)
The change for each patient was calculated as mean 24 hour DBP during cycle 2 - mean 24 hour DBP during cycle 1
Time frame: 2 cycles
Response Rate
Percentage of patients with a complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: 2 years
Change in Tumor Size From Baseline
Time frame: 2 years
Progression Free Survival
Time to progression or death from any cause, whichever comes first
Time frame: 2 years
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Bevacizumab at 15 mg/kg intravenously over 90 minutes