Sunitinib as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Conditions
Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Non-Small Cell Lung Cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: malate Given orally
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

- Evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis
Location
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing, China
Status: Recruiting
Contact: yang zhenzhou, doctor - yangzhenzhou@sohu.com
Start Date
September 2010
Completion Date
March 2012
Sponsors
Third Military Medical University
Source
Third Military Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page