Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] Versus Standard Chemotherapy in Patients With Previously Untreated Advanced NSCLC and a Poor Performance Status
Verified date | August 2012 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.
Status | Completed |
Enrollment | 103 |
Est. completion date | March 2007 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Stage IIIB or IV Nonsmall cell lung cancer (NSCLC) - No prior chemotherapy - Eastern Cooperative Oncology Group (ECOG) Performance Status 2 - Clinically or radiologically measurable disease per RECIST criteria Exclusion Criteria: - Gastro-intestinal abnormalities - Any concurrent anticancer therapy - Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind - Other active malignancies - Uncontrolled brain metastases - Severe abnormalities of the cornea - Significant cardiac disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Maryland Hematology/Oncology Associates | Baltimore | Maryland |
United States | FEK Addo, PC | Bismarck | North Dakota |
United States | Gabrail Cancer Center | Canton | Ohio |
United States | Charleston Hematology Oncology | Charleston | South Carolina |
United States | University Hospitals of Cleveland | Cleveland | Ohio |
United States | Ohio State University | Columbus | Ohio |
United States | Evanston Northwestern Healthcare | Evanston | Illinois |
United States | Holy Cross Hospital | Fort Lauderdale | Florida |
United States | California Cancer Care, Inc. | Greenbrae | California |
United States | East Tennessee Oncology/Hematology, PC | Knoxville | Tennessee |
United States | Norton Healthcare, Inc. | Louisville | Kentucky |
United States | University of Miami | Miami | Florida |
United States | Mount Sinai Cancer Center | Miami Beach | Florida |
United States | Sarah Cannon Cancer Center | Nashville | Tennessee |
United States | Weill Medical College of Cornell University | New York | New York |
United States | Oncology/Hematology Associates of Central Illinois | Peoria | Illinois |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
United States | VA Sierra Nevada Health Care System | Reno | Nevada |
United States | Sharp Clinical Oncology Research | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
OSI Pharmaceuticals |
United States,
Lilenbaum R, Axelrod R, Thomas S, Dowlati A, Seigel L, Albert D, Witt K, Botkin D. Randomized phase II trial of erlotinib or standard chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2. J Clin Oncol. 2008 Feb 2 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival | Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression. | Until time of disease progression (maximum 5 months) | No |
Secondary | Overall Survival | Median number of months from first study treatment until time of death | From first study treatment until time of death (maximum 26.8 months) | No |
Secondary | Best Tumor Response | Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor 20% larger than at baseline. | While receiving study treatment (maximum 60 weeks) | No |
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