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.
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 nonsmall-cell-lung-cancer
Started Sep 2010
Shorter than P25 for phase_2 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 27, 2010
CompletedFirst Posted
Study publicly available on registry
September 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedSeptember 28, 2010
September 1, 2010
1.2 years
September 27, 2010
September 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival
2 years
Secondary Outcomes (1)
• 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
Study Arms (1)
Single arm
EXPERIMENTALPatients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.
Interventions
Patients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, 400042, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
yang zhenzhou, doctor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 27, 2010
First Posted
September 28, 2010
Study Start
September 1, 2010
Primary Completion
November 1, 2011
Study Completion
March 1, 2012
Last Updated
September 28, 2010
Record last verified: 2010-09