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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00085280 |
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This clinical trial is studying how well erlotinib works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Condition | Intervention |
---|---|
Lung Cancer |
Drug: erlotinib hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Study To Determine If Downstream Markers of EGFR Linked Signalling Pathways Predict Response To OSI-774 (Erlotinib) In First-Line Treatment Of Patients With Advanced Non-Small Cell Lung Cancer |
Estimated Enrollment: | 129 |
Study Start Date: | September 2004 |
Estimated Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot, multicenter study.
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients complete the Smoking Status Survey, a questionnaire regarding smoking habits, at baseline, and then every 3 months during study treatment.
After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 129 patients will be accrued for this study within 6 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC)*
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior chemotherapy for metastatic disease
Prior adjuvant chemotherapy for stage IB-IIIA disease OR chemoradiotherapy for stage IIIA or IIIB disease allowed provided both of the following criteria are met:
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Julie Brahmer, MD | Sidney Kimmel Comprehensive Cancer Center |
Investigator: | Anne M. Traynor, MD | University of Wisconsin, Madison |
Study ID Numbers: | CDR0000368459, ECOG-E3503 |
Study First Received: | June 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00085280 |
Health Authority: | United States: Food and Drug Administration |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Erlotinib Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |