Sunitinib Malate in Treating Patients With Small Cell Lung Cancer
RATIONALE: Sunitinib malate 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.
PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients with small cell lung cancer.
Drug: sunitinib malate
Other: laboratory biomarker analysis
Radiation: fludeoxyglucose F 18
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Sunitinib (SU011248) in Patients With Small Cell Lung Cancer Who Are Either Chemo-naïve (Extensive Disease) or Have a "Sensitive" Relapse|
- Disease control rate (percentage of patients with complete response, partial response, or stable disease) 8 weeks after beginning treatment according to RECIST criteria [ Designated as safety issue: No ]
- Response rate every 4 weeks according to RECIST criteria [ Designated as safety issue: No ]
- Duration of progression-free survival [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Duration of survival [ Designated as safety issue: No ]
- Toxicity according to NCI CTCAE version 3.0 [ Designated as safety issue: Yes ]
- Accuracy of FDG-PET scan as a potential early surrogate marker of antiangiogenic activity for response [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Study Completion Date:||September 2012|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
- To assess the therapeutic activity of sunitinib malate in patients with either chemonaïve extensive stage or sensitive relapsed small cell lung cancer.
- To characterize the safety of sunitinib malate in these patients.
- To determine the potential of FDG-PET-scan to serve as a surrogate marker of response for the antiangiogenic activity of the compound.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (chemonaïve extensive stage vs sensitive relapse at least 3 months after stopping chemotherapy).
Patients receive oral sunitinib malate once daily for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients undergo fludeoxyglucose F 18 positron emission tomography of the chest at week 4. Blood samples and bronchial washings and brushings may be collected at baseline and at 4 and 8 weeks after start of therapy for further analysis.
After completion of study treatment, patients are followed up every 3 months.
|Vrije Universiteit Medisch Centrum|
|Amsterdam, Netherlands, 1007 MB|
|Principal Investigator:||Egbert F. Smit, MD||Free University Medical Center|