Phase II Study Alimta and Gemzar + Avastin as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV NSCLC
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.
|Non-Small Cell Lung Cancer||Drug: Pemetrexed and Gemcitabine plus Bevacizumab||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Pemetrexed and Gemcitabine Plus Bevacizumab as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV Non-Small Cell Lung Cancer|
- Progression Free Survival (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. ]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 to Progression (TTP) [ Time Frame: TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), assessed up to 15 months. ]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.
- Overall Survival (OS) [ Time Frame: OS was measured from day 1 of treatment until time of death, assessed up to 20 months. ]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.
- Overall Response [ Time Frame: Response to treatment was assessed after every 8 weeks of treatment, up to 50 weeks. ]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.
|Study Start Date:||August 2007|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Drug: Pemetrexed and Gemcitabine plus Bevacizumab
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517595
|United States, Connecticut|
|Medical Oncology & Hematology|
|Waterbury, Connecticut, United States, 06708|
|United States, Georgia|
|Augusta Oncology Associates|
|Augusta, Georgia, United States, 30901|
|Central Georgia Cancer Care|
|Macon, Georgia, United States, 31201|
|Northwest Georgia Oncology Center|
|Marietta, Georgia, United States, 30060|
|United States, Montana|
|Hematology Oncology Centers of the Northern Rockies|
|Billings, Montana, United States, 59101|
|United States, Ohio|
|Tri-County Oncology Hematology Associates|
|Canton, Ohio, United States, 44718|
|United States, Oregon|
|Pacific Oncology, PC|
|Portland, Oregon, United States, 97225|
|United States, Pennsylvania|
|Pennsylvania Oncology Hematology Associates|
|Philadelphia, Pennsylvania, United States, 19106|
|United States, Tennessee|
|The West Clinic|
|Memphis, Tennessee, United States, 38120|
|United States, Virginia|
|Cancer Specialists of Tidewater|
|Chesapeake, Virginia, United States, 23320|
|Principal Investigator:||Johnetta L Blakely, MD||Accelerated Community Oncology Research Network|