Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC
NCT ID: NCT00294762
Last Updated: 2012-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
143 participants
INTERVENTIONAL
2006-01-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Erlotinib
150 mg erlotinib daily
Tarceva
oral tablet
Erlotinib + chemotherapy (intercalated)
carboplatin AUC 6 on Day 1 to 21 days, paclitaxel 200 mg/m2 on Day 1 to 21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
Tarceva
oral tablet
carboplatin
IV
paclitaxel
IV
Interventions
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Tarceva
oral tablet
carboplatin
IV
paclitaxel
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically documented non-small cell lung cancer (NSCLC)
* Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2
* Radiologically measurable or evaluable disease No prior chemotherapy
* 1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening
* Tumor tissue block or fine needle aspirate
Exclusion Criteria
* Other active malignancy
* Uncontrolled brain metastases
* GI abnormalities
* Severe abnormalities of the cornea
* Significant cardiac disease
* Active infection
18 Years
ALL
No
Sponsors
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OSI Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Central Hematology Oncology Medical Group Inc.
Alhambra, California, United States
Comprehensive Blood and Cancer Center(Part of TORI network)
Bakersfield, California, United States
Bay Area Cancer Research Group
Concord, California, United States
Virginia K. Crosson Cancer Center
Fullerton, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
UCLA Medical Center
Los Angeles, California, United States
North Valley Hematology/Oncology Medical GroupThe Thomas and Dorothy Leavey Cancer Center
Northridge, California, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States
Wilshire Oncology Medical GroupThe Robert and Beverly Lewis Family Cancer Care Center
Pomona, California, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States
Sansum Santa Barbara Medical Foundation Clinic
Santa Barbara, California, United States
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Rocky Mountain Cancer CenterResearch Department
Denver, Colorado, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
MD Anderson Cancer Ctr - Orlando
Orlando, Florida, United States
Gulfcoast Oncology Associates
Tampa, Florida, United States
Suburban Hematology-Oncology Associates
Lawrenceville, Georgia, United States
Central Georgia Cancer Care, P.C.
Macon, Georgia, United States
Rush-Presbyterian-St.Luke's Med Ctr
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Norton Healthcare, Inc.
Louisville, Kentucky, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Univ. of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Hematology Oncology Centers of Northern Rockies Research
Billings, Montana, United States
Alegent Healthcare
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
Hematology-Oncology Associates, SJ, PA - Virtua Health
Mount Holly, New Jersey, United States
Providence Portland Medical Center
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Pottsville Cancer Clinic
Pottsville, Pennsylvania, United States
Boston Baskin Cancer Groupd/b/a U. of Tennessee Cancer Inst.
Memphis, Tennessee, United States
The West Cancer Clinic
Memphis, Tennessee, United States
ACORN
Memphis, Tennessee, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
Cancer Specialists of Tidewater, Ltd.
Chesapeake, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
CR UK
Cambridge, , United Kingdom
Peterborough District Hospital
Cambridge, , United Kingdom
Beatson Oncology Centre
Glasgow, , United Kingdom
Mount Vernon Hospital
Middlesex, , United Kingdom
Countries
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Related Links
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OSI Pharmaceuticals website
Other Identifiers
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OSI-774-203
Identifier Type: -
Identifier Source: org_study_id