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Spots Global Cancer Trial Database for Sorafenib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Sorafenib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Official Title: Phase II Study of the Raf Kinase Inhibitor BAY43-9006 in Patients With Advanced Non-Small Cell Lung Cancer

Study ID: NCT00098540

Study Description

Brief Summary: This phase II trial is studying how well sorafenib works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor.

Detailed Description: PRIMARY OBJECTIVES: I. Determine the response rate in patients with stage IIIB or IV non-small cell lung cancer treated with sorafenib. II. Determine the clinical toxic effects of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the 24-week progression-free survival rate in patients treated with this drug. II. Determine the overall survival of patients treated with this drug. III. Determine the time to disease progression in patients treated with this drug. IV. Correlate predictive disease markers (K-ras and B-raf mutations and ERK/pERK, AKT/pAKT, and VEGFR2/p-VEGFR2 expression) in these patients with the activity of this drug. OUTLINE: This is a multicenter study. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for up to 5 years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

North Central Cancer Treatment Group, Rochester, Minnesota, United States

Contact Details

Name: Alex Adjei

Affiliation: North Central Cancer Treatment Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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