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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00693992 |
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 more effective than a placebo in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying sunitinib to see how well it works when given as maintenance therapy compared with a placebo in treating patients with stage III or stage IV non-small cell lung cancer previously treated with combination chemotherapy.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: placebo Drug: sunitinib malate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511, IND #74019) as Maintenance Therapy in Non-Progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB / IV Non-Small Cell Lung Cancer |
Estimated Enrollment: | 156 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral sunitinib malate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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Drug: sunitinib malate
Given orally
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Arm II: Placebo Comparator
Patients receive oral placebo once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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Drug: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0 vs 1), disease stage (IIIB vs IV), prior treatment with bevacizumab (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC)
Must have received one prior first-line chemotherapy regimen that included 4 courses of platinum-based doublet chemotherapy with or without bevacizumab (bevacizumab may not have been given beyond the fourth course of chemotherapy)
Measurable or nonmeasurable disease
Nonmeasurable disease is defined as all other lesions, including small lesions (longest diameter < 20 mm by conventional techniques or < 10 mm by spiral CT scan), truly nonmeasurable lesions, and any of the following:
PATIENT CHARACTERISTICS:
No history of New York Heart Association (NYHA) class III-IV heart failure within the past 12 months
History of NYHA class II heart failure allowed provided at least one of the following criteria are met:
No history of pulmonary hemorrhage, bleeding diathesis, or evidence of hemoptysis
PRIOR CONCURRENT THERAPY:
More than 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
More than 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:
No concurrent agents with proarrhythmic potential, including any of the following:
No concurrent therapeutic anticoagulation for thromboembolic disease
Study Chair: | Mark A. Socinski, MD | UNC Lineberger Comprehensive Cancer Center |
Investigator: | Nithya Ramnath, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000597649, CALGB-30607 |
Study First Received: | June 6, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00693992 |
Health Authority: | Unspecified |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Sunitinib Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Growth Substances |
Therapeutic Uses Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |