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RATIONALE: PF-00299804 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether PF-00299804 is more effective than a placebo in treating patients with advanced non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying PF-00299804 to see how well it works compared with a placebo in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to standard therapy for advanced or metastatic cancer.
- To compare overall survival in patients with stage IIIB or IV non-small cell lung cancer receiving PF-00299804 who have failed standard therapy for advanced or metastatic disease.
- To compare overall survival in KRAS-WT patients.
- To compare overall survival in EGFR-mutant patients.
- To compare progression-free survival of these patients.
- To compare objective response rates in these patients.
- To estimate time to response and response duration in these patients.
- To evaluate the nature, severity, and frequency of toxicities in these patients.
- To compare quality of life of these patients.
- To determine the incremental cost-effectiveness and cost-utility ratios for PF-00299804.
- To correlate the expression of tumor and blood markers (at diagnosis) with outcomes and response.
OUTLINE: This is a multicenter study. Patients are stratified according to center, performance status (0 or 1 vs 2 or 3), tobacco use (never vs past or present), best response to prior EGFR tyrosine kinase inhibitor (progressive disease vs other), weight loss (< 5% vs ≥ 5% or unknown), and ethnicity (East Asian vs other). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Blood, serum, plasma, and tissue samples are collected and examined for biomarkers and gene mutations, and may be banked for future studies.
Patients complete quality-of-life questionnaires EORTC QLQ-C30 and other questionnaires at baseline and then periodically during and after completion of study treatment.
Cost effectiveness and cost utility of PF-00299804 is assessed via the Health Utilities Index (EQ-5D) and the Resource Utilization Assessment periodically.
After completion of study treatment, patients are followed at 4 weeks and then every 12 weeks thereafter.
Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
PF-00299804, gene expression analysis, mutation analysis, laboratory biomarker analysis, questionnaire administration, quality-of-life assessment
Margaret and Charles Juravinski Cancer Centre
NCIC Clinical Trials Group
Published on BioPortfolio: 2014-07-23T21:12:22-0400
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