Sunitinib as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Drug: malate Given orally
- Registration Number
- NCT01210053
- Lead Sponsor
- Third Military Medical University
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- No evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis
- Histologically or cytologically confirmed primary non-small cell lung cancer who have stable or responding disease after prior treatment with 3-6 courses of platinum -based therapy
- Not a candidate for combined modality therapy
- No cavitary lesions
- Evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm malate Given orally Patients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Progression-free survival 2 years
- Secondary Outcome Measures
Name Time Method • Grade and type of toxicity • 1-year survival rate • Response rate • Overall survival • Grade and type of toxicity • 1-year survival rate • Response rate • Overall survival 2 years
Trial Locations
- Locations (1)
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
🇨🇳Chongqing, Chongqing, China