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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01210053
• Other study ID #: Yang-001
• Status: Recruiting
• Phase: Phase 2
• First received: September 27, 2010
• Last updated: September 27, 2010
• Start date: September 2010
• Est. completion date: March 2012

Study information

• Verified date: September 2010
• Source: Third Military Medical University
• Contact: yang zhenzhou, doctor
• Email: yangzhenzhou[@]sohu.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• malate Given orally
Patients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.

Locations

Country	Name	City	State
China	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		2 years	Yes
Secondary	• 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	Yes