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RATIONALE: Drugs used in chemotherapy, such as sorafenib, work in different ways to stop tumor cells from dividing so they stop growing or die.
- Compare the percent of patients with refractory non-small cell lung cancer maintaining stable disease or objective response 2 months after treatment with sorafenib vs placebo.
- Compare median survival, progression-free survival, and response rate in patients treated with these regimens.
- Correlate ERK and pERK expression with response rate, stable disease, survival, and time to progression in patients treated with these regimens.
- Correlate a pattern of serum proteins present before treatment with sorafenib-related clinical benefits (e.g., response, time to progression, and/or survival) in these patients.
- Correlate plasma levels of VEGF and other biomarkers with outcome in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to number of prior chemotherapy regimens (2 vs more than 2) and prior epidermal growth factor receptor inhibitor treatment (yes vs no).
- Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.
- Randomization: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral placebo twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients who develop disease progression within 1 year after randomization cross over to arm I.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 311 patients will be accrued for this study within approximately 3 years.
Allocation: Randomized, Control: Active Control, Masking: Double-Blind, Primary Purpose: Treatment
Stanford Comprehensive Cancer Center - Stanford
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:55:06-0400
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Tumors or cancer of the LUNG.
Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.
Nuclear phosphoprotein encoded by the p53 gene (GENES, P53) whose normal function is to control CELL PROLIFERATION and APOPTOSIS. A mutant or absent p53 protein has been found in LEUKEMIA; OSTEOSARCOMA; LUNG CANCER; and COLORECTAL CANCER.
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.
A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA).
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