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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
Not Enrolling
Both
Non-Small Cell Lung Cancer

Thank you

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