NCT00087412

S0341: Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer

Phase II Trial of OSI-774 (NSC-718781) in Patients With Advanced Non-Small Cell Lung Cancer and a Performance Status of 2

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well erlotinib works in treating patients with advanced primary non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth

Detailed description

PRIMARY OBJECTIVES: I. To assess survival in patients with advanced non-small cell lung carcinoma with a Zubrod Performance Status of 2 treated with OSI-774. II. To evaluate the objective tumor response rates (confirmed plus unconfirmed, complete and partial), in patients with advanced non-small cell lung carcinoma with a Zubrod Performance Status of 2 treated with OSI-774. III. To investigate in a preliminary manner possible correlations of EGFR expression, mutations, and/or EGFR polymorphisms with response and/or survival. IV. To investigate in a preliminary manner possible correlations of activated signal pathway molecules, including basal p27 expression levels with response and/or survival. OUTLINE: This is a multicenter study. Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

Conditions

• Adenocarcinoma of the Lung
• Large Cell Lung Cancer
• Recurrent Non-small Cell Lung Cancer
• Squamous Cell Lung Cancer
• Stage IIIB Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-09-01
• Primary completion: 2007-07-01
• First posted: 2004-07-12
• Last updated: 2013-02-28

Locations

1 site across 1 country: United States