Sunitinib as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
NCT ID: NCT01210053
Last Updated: 2010-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2010-09-30
2012-03-31
Brief Summary
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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
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single arm
Patients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.
malate Given orally
Patients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.
Interventions
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malate Given orally
Patients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Third Military Medical University
OTHER
Responsible Party
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Third Military Medical University
Principal Investigators
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yang zhenzhou, doctor
Role: PRINCIPAL_INVESTIGATOR
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Locations
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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Yang-001
Identifier Type: -
Identifier Source: org_study_id