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Sorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer

2014-08-27 03:55:06 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as sorafenib, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works compared to placebo in treating patients with refractory non-small cell lung cancer.

Description

OBJECTIVES:

- 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.

Study Design

Allocation: Randomized, Control: Active Control, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

sorafenib tosylate

Location

Stanford Comprehensive Cancer Center - Stanford
Stanford
California
United States
94305

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:06-0400

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PubMed Articles [15652 Associated PubMed Articles listed on BioPortfolio]

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Multiple Roles of Autophagy in the Sorafenib Resistance of Hepatocellular Carcinoma.

Hepatocellular carcinoma (HCC) is the second leading cause of cancer-related death worldwide, and prognosis remains unsatisfactory since the disease is often diagnosed at the advanced stages. Currentl...

Lower expression level of IL-33 is associated with poor prognosis of pulmonary adenocarcinoma.

Lung cancer is one of the deadliest malignancies. The immune checkpoint-blockade (ICB) tumor therapy has led to striking improvement of long-term survival for some lung cancer patients. However, the r...

Inhibition of pMAPK14 Overcomes Resistance to Sorafenib in Hepatoma Cells with Hepatitis B Virus.

Hepatitis B virus (HBV) targets the liver and is a major driver for liver cancer. Clinical data suggest that HBV infection is associated with reduced response to treatment with the multi-kinase inhibi...

Effect of 5,7-dimethoxyflavone on Bcrp1-mediated transport of sorafenib in vitro and in vivo in mice.

Tyrosine kinase inhibitors (TKI) are a novel and target-specific class of anticancer drugs. One drawback of TKI therapy is cancer resistance to TKI. An important TKI resistance mechanism is enhanced e...

Medical and Biotech [MESH] Definitions

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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