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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00087412 |
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with advanced primary non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: erlotinib hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial Of OSI-774 (NSC-718781) In Patients With Advanced Non-Small Cell Lung Cancer And A Performance Status Of 2 |
Study Start Date: | September 2004 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC) meeting 1 of the following stage criteria:
Selected stage IIIB disease (excluding Pancoast tumors)
Stage IV disease
The following histologies are eligible:
Measurable disease by CT scan, MRI, x-ray, or physical or nuclear exam
No brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Bilirubin ≤ upper limit of normal (ULN) AND 1 of the following:
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No concurrent radiotherapy to measurable or non-measurable lesions
Surgery
Other
Study Chair: | Paul J. Hesketh, MD | Caritas St. Elizabeth's Medical Center of Boston |
Investigator: | Antoinette J. Wozniak, MD | Barbara Ann Karmanos Cancer Institute |
Study ID Numbers: | CDR0000377245, SWOG-S0341 |
Study First Received: | July 8, 2004 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00087412 |
Health Authority: | United States: Federal Government |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer |
adenocarcinoma of the lung large cell lung cancer squamous cell lung cancer |
Erlotinib Thoracic Neoplasms Non-small cell lung cancer Adenocarcinoma of lung Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Adenocarcinoma 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 |