The primary objective is to determine the progression free survival with pemetrexed, and gemcitabine plus bevacizumab as first-line chemotherapy in elderly patients with Stage IIIB/IV non-small cell lung cancer (NSCLC). The secondary objectives are to determine the overall response rate; overall survival; chemotherapy induced toxicity profile of this combination; time to progression; and patient reported symptom burden.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Bevacizumab 10 mg/kg will be given intravenously according to weight. Pemetrexed 500 mg/m\^2 and gemcitabine 1500 mg/m\^2 will be given intravenously according to weight and height. All agents are administered every 2 weeks.
Medical Oncology & Hematology
Waterbury, Connecticut, United States
Augusta Oncology Associates
Augusta, Georgia, United States
Central Georgia Cancer Care
Macon, Georgia, United States
Progression Free Survival (PFS)
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. 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. The median progression free survival is the parameter used to describe PFS.
Time frame: PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months.
Time to Progression (TTP)
Time to progression is defined as the time from treatment start until objective tumor progression. 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. The median time to progression is the parameter used to describe TTP.
Time frame: TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), assessed up to 15 months.
Overall Survival (OS)
Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.
Time frame: OS was measured from day 1 of treatment until time of death, assessed up to 20 months.
Overall Response
Response was evaluated via changes from baseline in radiological tumor measurements performed after every 4th treatment cycle and at the end of treatment or time of progression. 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; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of \>=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Northwest Georgia Oncology Center
Marietta, Georgia, United States
Hematology Oncology Centers of the Northern Rockies
Billings, Montana, United States
Tri-County Oncology Hematology Associates
Canton, Ohio, United States
Pacific Oncology, PC
Portland, Oregon, United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States
The West Clinic
Memphis, Tennessee, United States
Cancer Specialists of Tidewater
Chesapeake, Virginia, United States
Time frame: Response to treatment was assessed after every 8 weeks of treatment, up to 50 weeks.