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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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Sorafenib Tosylate With or Without Pravastatin in Treating Patients With Liver Cancer and Cirrhosis

RATIONALE: Sorafenib tosylate and pravastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of live...

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This phase Ib/II trial studies how well sorafenib tosylate and pembrolizumab work in treating patients with liver cancer that has spread to other parts of the body. Sorafenib tosylate may ...

Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer

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Temsirolimus and Sorafenib Tosylate in Treating Patients With Advanced Liver Cancer and Liver Dysfunction

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Sorafenib Tosylate in Treating Patients With Liver Cancer Who Have Undergone a Liver Transplant

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PubMed Articles [15345 Associated PubMed Articles listed on BioPortfolio]

Downregulation of Raf-1 kinase inhibitory protein as a sorafenib resistance mechanism in hepatocellular carcinoma cell lines.

Although sorafenib enhances overall survival, sorafenib resistance has been reported to be a significant limiting factor for improved prognosis in patients with hepatocellular carcinoma (HCC). Therefo...

The excellent antitumor effect of apatinib alone as second-line therapy in a patient with sorafenib-refractory hepatocellular carcinoma: A case report.

Hepatocellular carcinoma (HCC) is a highly invasive cancer associated with high mortality rates. Although sorafenib is currently recommended as standard treatment for advanced HCC, its treatment effic...

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...

Berberine, a natural plant alkaloid, synergistically sensitizes human liver cancer cells to sorafenib.

Sorafenib resistance is one of the major factors affecting the prognosis of patients with hepatocellular carcinoma (HCC). Increasing evidence has indicated that certain traditional medicines can enhan...

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...

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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