Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy
|Stage IIIB Non-Small Cell Lung Cancer Stage IV Non-Small Cell Lung Cancer||Other: Laboratory Biomarker Analysis Other: Placebo Other: Quality-of-Life Assessment Drug: Sunitinib Malate||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
|Official Title:||Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511) 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|
- Progression Free Survival (PFS) [ Time Frame: Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years) ]Progression Free Survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.
- Overall Survival (OS) [ Time Frame: Time from randomization to death (up to 5 years) ]Overall survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.
- Response Rate (RR) [ Time Frame: Duration of treatment (up to 5 years) ]
The percentage of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.
- Percentage of Deterioration in QOL at 3 Months Using the EORTC QLQ-C30 Global Health Subscale [ Time Frame: At 3 months ]The percentage of patients with at least a 10% drop in the EORTC-QLQ-C30 Global Health Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.
- Percentage of Deterioration in Symptom Progression at 3 Months Using the EORTC LC13 Dyspnea Subscale [ Time Frame: At 3 months ]The percentage of patients with at least a 10% drop in the EORTC LC13 Dyspnea Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.
- Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: Duration of study (up to 5 years) ]Grade 3 or 4 adverse events which affected more than 5% of participants are summarized by arm.
- VEGF Levels and Correlation With Clinical Outcomes, Including RR, PFS, and OS [ Time Frame: Up to 6 weeks ]
|Study Start Date:||June 2008|
|Study Completion Date:||May 2015|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm I (sunitinib malate)
Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studiesOther: Quality-of-Life Assessment
Other Name: Quality of Life AssessmentDrug: Sunitinib Malate
Placebo Comparator: Arm II (placebo)
Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studiesOther: Placebo
Other Names:Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
I. To evaluate the effect of sunitinib (sunitinib malate) compared to placebo on progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients who have had either stable or responding disease over the course of their initial 4 cycles of platinum-based therapy.
I. To evaluate the toxicity of sunitinib compared to placebo in the maintenance setting.
II. To evaluate the additional response rate as a result of sunitinib in this setting.
III. To assess the impact of sunitinib on overall survival compared to the placebo arm.
IV. To assess the impact of sunitinib on delaying the time to deterioration in quality of life and symptom progression compared to placebo using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and Lung Cancer Module (LC13).
V. To assess vascular endothelial growth factor (VEGF) haplotypes in advanced non-small cell lung cancer and sunitinib maintenance.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 1 year, and then periodically for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693992
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|Principal Investigator:||Mark Socinski||Alliance for Clinical Trials in Oncology|