Sunitinib as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
malate Given orally
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-Small Cell Lung Cancer
Eligibility 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
Sites / Locations
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
Patients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.
Outcomes
Primary Outcome Measures
Progression-free survival
Secondary Outcome Measures
• 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
Full Information
NCT ID
NCT01210053
First Posted
September 27, 2010
Last Updated
September 27, 2010
Sponsor
Third Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01210053
Brief Title
Sunitinib as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Third Military Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Arm Description
Patients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
malate Given orally
Other Intervention Name(s)
sutent
Intervention Description
Patients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
• 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
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yang zhenzhou, doctor
Email
yangzhenzhou@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yang zhenzhou, doctor
Organizational Affiliation
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yang zhenzhou, doctor
Email
yangzhenzhou@sohu.com
12. IPD Sharing Statement
Learn more about this trial
Sunitinib as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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