A Study to Evaluate Tarceva in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT00091663
Last Updated: 2014-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
5000 participants
INTERVENTIONAL
2004-08-31
2005-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Tarceva (erlotinib HCl)
Eligibility Criteria
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Inclusion Criteria
* Inoperable and incurable, locally advanced, recurrent or metastatic NSCLC
* Relapse following standard chemotherapy (combination chemotherapy such as two-drug combination chemotherapy, or a single-agent chemotherapy agent for elderly or poor performance status patients)
* Age \>=18 years
* ECOG performance status of 0 to 3
* Recovered from the toxic effects of prior therapy
* Able to comply with study and follow-up procedures
* Able to take oral medication
* Use of an effective means of contraception (for patients with reproductive potential)
* Granulocyte count \>=1.0 x 10\^9/L
* Platelet count \>=75 x 10\^9/L
* Serum bilirubin \<1.5 x upper limit of normal (ULN)
* SGOT (AST) \<2 x ULN unless elevation is clearly due to liver metastases; then SGOT (AST) must be \<5 x ULN
* Serum creatinine \<=1.5 mg/dL
Exclusion Criteria
* Prior therapy with any systemic HER1/EGFR small molecule inhibitor, including gefitinib (Iressa), erlotinib (Tarceva), or other investigational agents in this class
* History of another malignancy in the past 2 years unless the malignancy has been adequately treated and is associated with a 5-year anticipated survival of \>=90%
* Known central nervous system (CNS) metastases that have not yet been definitively treated with surgery and/or radiation or that are symptomatic or unstable
* Nursing mothers or pregnant females
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Locations
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Comprehensive Cancer Institute
Huntsville, Alabama, United States
Hematology-Oncology Specialist, Center for Cancer Care
Huntsville, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Palo Verde Hematology/Oncology, Ltd.
Glendale, Arizona, United States
Arizona Hematology Oncology, PC
Tucson, Arizona, United States
Little Rock Hematology Oncology Associates
Little Rock, Arkansas, United States
Tower Hematology Oncology Medical Group
Beverly Hills, California, United States
Southbay Oncology Hematology Partners
Campbell, California, United States
Antelope Valley Cancer Center
Lancaster, California, United States
Clinical Trials and Research Associates, Inc.
Montebello, California, United States
Cancer and Blood Institute Medical Group
Rancho Mirage, California, United States
Los Palos Oncology and Hematology Center
Salinas, California, United States
Naveen Gupta, MD, Inc.
Upland, California, United States
Hematology Oncology, PC
Stamford, Connecticut, United States
Lee Cancer Clinic
Fort Myers, Florida, United States
Florida Wellcare Alliance
Inverness, Florida, United States
Florida Oncology Associates
Jacksonville, Florida, United States
Osceola Cancer Center
Kissimmee, Florida, United States
Florida Cancer Institute
New Port Richey, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Mid-Florida Hematology & Oncology Centers, P.A.
Orange City, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Metcare Oncology
Ormond Beach, Florida, United States
Hematology Oncology Associates
Pensacola, Florida, United States
Oncology and Hematology Associates of West Broward P.A.
Tamarac, Florida, United States
Bay Area Oncology
Tampa, Florida, United States
Space Coast Medical Associates
Titusville, Florida, United States
Hematology & Oncology of NE Georgia, PC
Athens, Georgia, United States
St. Luke's Mountain States Tumor Institute
Boise, Idaho, United States
Northwest Medical Specialists
Arlington Heights, Illinois, United States
Hematology Oncology Consultants
Naperville, Illinois, United States
Cedar Valley Medical Specialists, PC
Waterloo, Iowa, United States
Kentucky Cancer Clinic
Hazard, Kentucky, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Louisiana Oncology Associates, PMC
Lafayette, Louisiana, United States
Maine Center for Cancer Medicine & Blood Disorders
Scarborough, Maine, United States
Annapolis Medical Specialists, LLC
Annapolis, Maryland, United States
Maryland Hematology/Oncology Associates, PA
Baltimore, Maryland, United States
Center for Cancer and Blood Disorders, P.C.
Bethesda, Maryland, United States
Berkshire Hematology Oncology, PC
Pittsfield, Massachusetts, United States
West Michigan Regional Cancer & Blood Center
Free Soil, Michigan, United States
Kalamazoo Hematology and Oncology
Kalamazoo, Michigan, United States
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, United States
Essex Oncology of North Jersey
Belleville, New Jersey, United States
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States
Combined Hematology Oncology Practice of New Jersey
Jersey City, New Jersey, United States
Hematology Oncology Associates of Western Suffolk, PC
Bay Shore, New York, United States
Nassau Hematology Oncology, P.C.
Lake Success, New York, United States
Crystal Run Healthcare
Middletown, New York, United States
Westchester Hematology Oncology Associates
Mount Kisco, New York, United States
Upstate NY Cancer Research and Education Foundation
Rochester, New York, United States
Staten Island Medical Group
Staten Island, New York, United States
Cancer Care of WNC
Asheville, North Carolina, United States
Gaston Hematology and Oncology
Gastonia, North Carolina, United States
Northwestern Carolina Oncology & Hematology, PA
Hickory, North Carolina, United States
Piedmont Oncology Specialists
Monroe, North Carolina, United States
Lake Norman Hematology/ Oncology Specialists
Mooresville, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Hematology Oncology Consultants, Inc.
Columbus, Ohio, United States
The Gerad Center for Cancer Treatment
Lima, Ohio, United States
Ohio Cancer Specialists, Inc.
Mansfield, Ohio, United States
Signal Point Hematology/Oncology, Inc.
Middletown, Ohio, United States
Comprehensive Cancer Center
Oklahoma City, Oklahoma, United States
Oncology Hematology Associates of Northern Pennsylvania, PC
DuBois, Pennsylvania, United States
Satish A. Shah, MD, PC
Gettysburg, Pennsylvania, United States
Drs. Sambandam & Joseph Associates, Inc.
Cranston, Rhode Island, United States
Charleston Cancer Center
Charleston, South Carolina, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States
Santee Hematology/Oncology
Sumter, South Carolina, United States
Sioux Valley Clinic
Sioux Falls, South Dakota, United States
Blue Ridge Medical Specialists
Bristol, Tennessee, United States
The Family Cancer Center
Collierville, Tennessee, United States
C. Michael Jones, MD PC
Germantown, Tennessee, United States
McLeod Cancer & Blood Center
Johnson City, Tennessee, United States
The Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Southwest Regional Cancer Center
Austin, Texas, United States
Lone Star Oncology Consultants, PA
Austin, Texas, United States
Coastal Bend Oncology Hematology
Corpus Christi, Texas, United States
Center for Oncology Research and Treatment P. A.
Dallas, Texas, United States
Texas Cancer Associates, LLP
Dallas, Texas, United States
Texas Hematology/Oncology Center, P.A.
Dallas, Texas, United States
Steve Perkins, MD, PA
Dallas, Texas, United States
Utah Hematology and Oncology
Ogden, Utah, United States
Rutland Regional Medical Center
Rutland, Vermont, United States
Cancer Outreach Association, LLC
Abingdon, Virginia, United States
Arlington Fairfax Hematology Oncology, P.C.
Arlington, Virginia, United States
Lynchburg Hematology Oncology Clinic, Inc.
Lynchburg, Virginia, United States
Cascade Cancer Center
Kirkland, Washington, United States
NW Cancer Specialists
Vancouver, Washington, United States
Ministry Medical Group
Rhinelander, Wisconsin, United States
Countries
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References
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Spigel DR, Lin M, O'Neill V, Hainsworth JD. Final survival and safety results from a multicenter, open-label, phase 3b trial of erlotinib in patients with advanced nonsmall cell lung cancer. Cancer. 2008 Jun 15;112(12):2749-55. doi: 10.1002/cncr.23490.
Other Identifiers
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OSI3199g
Identifier Type: -
Identifier Source: org_study_id
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