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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00087412 |
Purpose
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: | Masking: Open Label Primary Purpose: Treatment |
| 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.
Eligibility| 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
Contacts and Locations
Show 128 Study Locations| Study Chair: | Paul J. Hesketh, MD | Steward St. Elizabeth's Medical Center of Boston, Inc. |
| Principal Investigator: | Antoinette J. Wozniak, MD | Barbara Ann Karmanos Cancer Institute |
More Information
| Responsible Party: | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT00087412 History of Changes |
| Other Study ID Numbers: | CDR0000377245, SWOG-S0341 |
| Study First Received: | July 8, 2004 |
| Last Updated: | July 18, 2011 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
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 |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |