Phase II Study of ABI-007 Plus Sunitinib as First Line Treatment for Non-Small Cell Lung Cancer
- To determine the tumor response rate in patients with stage IV non-small cell lung
cancer treated with paclitaxel albumin-stabilized nanoparticle formulation and
sunitinib malate as first-line therapy.
- To determine the time to objective tumor response and duration of response in
- To determine the time to treatment failure and overall survival of these patients.
- To characterize the toxicities of this regimen in these patients.
OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30
minutes on days 1, 8, and 15. Patients also receive oral sunitinib malate once daily on days
1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or
After completion of study therapy, patients are followed every 8 weeks until disease
progression and then every 3 months for up to 1 year.
Masking: Open Label, Primary Purpose: Treatment
Arkadiusz Dudek, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration