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
- 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
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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease control rate (percentage of patients with complete response, partial response, or stable disease) 8 weeks after beginning treatment according to RECIST criteria
Egbert F. Smit, MD
Free University Medical Center
United States: Federal Government