NCT01210053

Sunitinib as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

This Phase II Trial is Studying Sunitinib to See How Well it Works When Given as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer Which is Previously Treated With Combination Chemotherapy.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Third Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: 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. It is not yet known whether sunitinib is effective in treating non-small cell lung cancer. PURPOSE: This phase II trial is studying sunitinib to see how well it works when given as maintenance therapy in treating patients with stage III or stage IV non-small cell lung cancer which is previously treated with combination chemotherapy.

Detailed description

OBJECTIVES: Primary * To investigate the effect of sunitinib malate on the progression-free survival of patients with stage IIIB or IV non-small cell lung cancer Secondary * To evaluate the toxicity of sunitinib when administered in the maintenance setting. * To evaluate the additional response rate to sunitinib malate when administered in the maintenance setting. * To evaluate the overall survival of patients treated with sunitinib. After completion of study treatment, patients are followed every 2 months for 1 year, every 6 months for 1 year, and periodically for 3 years.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	malate Given orally	Patients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-11-01
• Completion: 2012-03-01
• First posted: 2010-09-28
• Last updated: 2010-09-28

Locations

1 site across 1 country: China