NCT00953459

Sunitinib Malate in Treating Patients With Small Cell Lung Cancer

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * To assess the therapeutic activity of sunitinib malate in patients with either chemonaïve extensive stage or sensitive relapsed small cell lung cancer. Secondary * To characterize the safety of sunitinib malate in these patients. Tertiary * 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	sunitinib malate
OTHER	laboratory biomarker analysis
RADIATION	fludeoxyglucose F 18

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-07-01
• Completion: 2012-09-01
• First posted: 2009-08-06
• Last updated: 2018-07-26

Locations

1 site across 1 country: Netherlands