A Multicenter Phase II Trial of Carboplatin, Pemetrexed, and Bevacizumab Followed By Pemetrexed and Bevacizumab Maintenance Therapy in Patients With a Light or Never Smoking History
- To estimate the progression-free survival (PFS) of patients with advanced non-small
cell lung cancer who are never or light smokers treated with carboplatin, pemetrexed
disodium, and bevacizumab followed by pemetrexed disodium and bevacizumab maintenance
- To estimate the overall survival (OS) of patients treated with this regimen.
- To estimate the toxicity of treatment using the NCI CTCAE version 3.0.
- To conduct an exploratory analysis of molecular markers (e.g., KRAS and EGFR mutations)
in patients with a never or light smoking history and to analyze any potential
association with response, PFS, and OS.
- To assess response to second-line erlotinib hydrochloride therapy according to RECIST
OUTLINE: This is a multicenter study.
- First-line therapy: Patients receive pemetrexed disodium IV over 10 minutes,
carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Treatment repeats every 21 days for 4 courses in the absence of disease progression or
unacceptable toxicity. Patients who achieve partial or complete response or have stable
disease progress to maintenance therapy.
- Maintenance therapy: Patients receive pemetrexed disodium IV over 10 minutes and
bevacizumab IV over 30 minutes on day 1. Treatment repeats every 21 days in the absence
of disease progression or unacceptable toxicity.
Patients who experience disease progression or unacceptable toxicity may receive second-line
therapy with erlotinib hydrochloride as part of standard-of-care treatment.
Tissue samples are collected at baseline for laboratory biomarker analysis.
After completion of maintenance therapy, patients are followed every 4 weeks for 2 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Documented radiographic response per RECIST criteria each year, until subject death
Thomas E. Stinchcombe, MD
UNC Lineberger Comprehensive Cancer Center
United States: Food and Drug Administration
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|University of Pittsburgh Medical Center||Pittsburgh, Pennsylvania 15213|
|Leo W. Jenkins Cancer Center at ECU Medical School||Greenville, North Carolina 27834|
|Mission Hospital||Asheville, North Carolina 28801|
|CCHC New Bern Cancer Care||New Bern, North Carolina 28562|