The purpose of this trial is to evaluate three treatment regimens in patients with stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) with a performance status of 2 and who were not previously treated.
This randomized, Phase II trial will evaluate three treatment regimens in patients with previously untreated stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) and a performance status (PS) of 2. Patients will be randomized to either pemetrexed alone, pemetrexed and bevacizumab, or pemetrexed, carboplatin, and bevacizumab in a 1:1:1 fashion. All 3 regimens should be tolerable in poor performance status patients with advanced NSCLC. The 3-drug regimen (pemetrexed/carboplatin/bevacizumab) has been modified by lowering the dose of carboplatin, in order to minimize myelosuppression. This trial will be conducted at multiple study sites.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
500 mg/m2 IV given over 10 minutes every 21 days
15 mg/kg IV every 21 days
AUC=5 IV every 21 days
Progression Free Survival (PFS)
The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: 18 months
Overall Response Rate (ORR), the Number of Patients Who Experience an Objective Benefit From Treatment
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: 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: 18 months
Time to Progression (TTP)
The Length of Time, in Months, That Patients Remain Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: 18 months
Time to Treatment Failure (TTTF)
Defined as the Length of Time, in Months, that Patients were Alive from the Date of First Treatment Until Treatment Discontinuation for Any Reason.
Time frame: 18 months
Overall Survival (OS)
The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Time frame: 18 months
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Mayo Clinic - AZ
Scottsdale, Arizona, United States
Genesis Cancer Center
Hot Springs, Arkansas, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States
Wilshire Oncology Medical Group
LaVerne, California, United States
Aventura Medical Center
Aventura, Florida, United States
Collaborative Research Group/ Palm Beach Ins of Hem Onc
Boynton Beach, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Memorial Regional Cancer Center
Hollywood, Florida, United States
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States
...and 17 more locations
6-month and 12-month Overall Survival Probability
Overall Survival = The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Time frame: 12 months