Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Sunitinib as First-Line Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving paclitaxel albumin-stabilized nanoparticle formulation together with sunitinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized nanoparticle formulation together with sunitinib works as first-line therapy in treating patients with stage IV non-small cell lung cancer.
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Drug: sunitinib malate
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of ABI-007 Plus Sunitinib as First Line Treatment for Non-Small Cell Lung Cancer|
- Response rate [ Designated as safety issue: No ]
- Time to objective tumor response as assessed by RECIST criteria [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Toxicity and adverse events as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
|Study Start Date:||August 2008|
Experimental: Stage IV Non-Small Cell Lung Cancer Patients
Patients with stage IV non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate as first-line therapy.
|Drug: paclitaxel albumin-stabilized nanoparticle formulation Drug: sunitinib malate|
- 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 responding patients.
- 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 unacceptable toxicity.
After completion of study therapy, patients are followed every 8 weeks until disease progression and then every 3 months for up to 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00748163
|Principal Investigator:||Arkadiusz Dudek, MD||Masonic Cancer Center, University of Minnesota|