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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free Survival
Outcome Description:
Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
Outcome Time Frame:
Until time of disease progression (maximum 5 months)
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
OSI-774-201
NCT ID:
NCT00085839
Start Date:
February 2004
Completion Date:
March 2007
Related Keywords:
- Non-Small Cell Lung Cancer
- Tarceva
- NSCLC
- EGFR
- ECOG Performance Status 2
- erlotinib
- Non-Small Cell Lung Cancer
- OSI-774
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| University Hospitals of Cleveland | Cleveland, Ohio 44106 |
| Weill Medical College of Cornell University | New York, New York 10021 |
| California Cancer Care, Inc. | Greenbrae, California 94904-2007 |
| Evanston Northwestern Healthcare | Evanston, Illinois 60201 |
| Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
| Maryland Hematology/Oncology Associates | Baltimore, Maryland 21236 |
| Ohio State University | Columbus, Ohio 43210 |
| Sarah Cannon Cancer Center | Nashville, Tennessee 37203 |
| Norton Healthcare, Inc. | Louisville, Kentucky 40202 |
| Charleston Hematology Oncology | Charleston, South Carolina 29403 |
| Gabrail Cancer Center | Canton, Ohio 44718 |
| University of Miami | Miami, Florida 33136 |
| Thomas Jefferson University Hospital | Philadelphia, Pennsylvania 19131 |
| Sharp Clinical Oncology Research | San Diego, California 92123 |
| VA Sierra Nevada Health Care System | Reno, Nevada 89502 |
| Mount Sinai Cancer Center | Miami Beach, Florida 33140 |
| Oncology/Hematology Associates of Central Illinois | Peoria, Illinois 61615 |
| FEK Addo, PC | Bismarck, North Dakota 58503 |
| East Tennessee Oncology/Hematology, PC | Knoxville, Tennessee 37920 |
