A Study to Evaluate Tarceva in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Non-small-cell Lung CarcinomaLung Cancer
- Registration Number
- NCT00091663
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This is a Phase IIIb, multicenter, open-label trial of daily oral Tarceva in patients with advanced (inoperable Stage IIIb or IV) NSCLC who have progressed following standard chemotherapy treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5000
- Written (signed) informed consent(s)
- 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
- Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within the last 6 months, hepatic, renal, or metabolic disease)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (92)
Antelope Valley Cancer Center
🇺🇸Lancaster, California, United States
Cancer and Blood Institute Medical Group
🇺🇸Rancho Mirage, California, United States
Utah Hematology and Oncology
🇺🇸Ogden, Utah, United States
Arizona Hematology Oncology, PC
🇺🇸Tucson, Arizona, United States
Palo Verde Hematology/Oncology, Ltd.
🇺🇸Glendale, Arizona, United States
Hematology Oncology, PC
🇺🇸Stamford, Connecticut, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Annapolis Medical Specialists, LLC
🇺🇸Annapolis, Maryland, 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
McLeod Cancer & Blood Center
🇺🇸Johnson City, Tennessee, United States
The Family Cancer Center
🇺🇸Collierville, Tennessee, United States
C. Michael Jones, MD PC
🇺🇸Germantown, Tennessee, United States
The Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States
Rutland Regional Medical Center
🇺🇸Rutland, Vermont, United States
Center for Cancer and Blood Disorders, P.C.
🇺🇸Bethesda, Maryland, United States
Florida Oncology Associates
🇺🇸Jacksonville, Florida, United States
Lee Cancer Clinic
🇺🇸Fort Myers, Florida, United States
Metcare Oncology
🇺🇸Ormond Beach, Florida, United States
Drs. Sambandam & Joseph Associates, Inc.
🇺🇸Cranston, Rhode Island, United States
Hematology-Oncology Specialist, Center for Cancer Care
🇺🇸Huntsville, Alabama, United States
Clinical Trials and Research Associates, Inc.
🇺🇸Montebello, California, United States
Naveen Gupta, MD, Inc.
🇺🇸Upland, California, United States
Hematology Oncology Associates
🇺🇸Pensacola, Florida, United States
Space Coast Medical Associates
🇺🇸Titusville, Florida, United States
Kentucky Cancer Clinic
🇺🇸Hazard, Kentucky, United States
Comprehensive Cancer Institute
🇺🇸Huntsville, Alabama, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
Tower Hematology Oncology Medical Group
🇺🇸Beverly Hills, California, United States
Maine Center for Cancer Medicine & Blood Disorders
🇺🇸Scarborough, Maine, United States
Bay Area Oncology
🇺🇸Tampa, Florida, United States
Northwest Medical Specialists
🇺🇸Arlington Heights, Illinois, United States
Cedar Valley Medical Specialists, PC
🇺🇸Waterloo, Iowa, United States
Louisiana Oncology Associates, PMC
🇺🇸Lafayette, Louisiana, United States
Berkshire Hematology Oncology, PC
🇺🇸Pittsfield, Massachusetts, United States
Maryland Hematology/Oncology Associates, PA
🇺🇸Baltimore, Maryland, United States
Signal Point Hematology/Oncology, Inc.
🇺🇸Middletown, Ohio, United States
Hematology Oncology Consultants, Inc.
🇺🇸Columbus, Ohio, United States
Hematology Oncology Associates of Western Suffolk, PC
🇺🇸Bay Shore, New York, United States
West Michigan Regional Cancer & Blood Center
🇺🇸Free Soil, Michigan, United States
Oncology Care Associates, P.L.L.C.
🇺🇸St. Joseph, Michigan, United States
Steve Perkins, MD, PA
🇺🇸Dallas, Texas, United States
Comprehensive Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Satish A. Shah, MD, PC
🇺🇸Gettysburg, Pennsylvania, United States
Staten Island Medical Group
🇺🇸Staten Island, New York, United States
Northwestern Carolina Oncology & Hematology, PA
🇺🇸Hickory, North Carolina, United States
Cancer Care of WNC
🇺🇸Asheville, North Carolina, United States
South Carolina Oncology Associates, PA
🇺🇸Columbia, South Carolina, United States
Sioux Valley Clinic
🇺🇸Sioux Falls, South Dakota, United States
Gaston Hematology and Oncology
🇺🇸Gastonia, North Carolina, United States
Southwest Regional Cancer Center
🇺🇸Austin, Texas, United States
Santee Hematology/Oncology
🇺🇸Sumter, South Carolina, United States
Coastal Bend Oncology Hematology
🇺🇸Corpus Christi, Texas, United States
Texas Hematology/Oncology Center, P.A.
🇺🇸Dallas, Texas, United States
Center for Oncology Research and Treatment P. A.
🇺🇸Dallas, Texas, United States
Arlington Fairfax Hematology Oncology, P.C.
🇺🇸Arlington, Virginia, United States
Ministry Medical Group
🇺🇸Rhinelander, Wisconsin, United States
Piedmont Oncology Specialists
🇺🇸Monroe, North Carolina, United States
Lone Star Oncology Consultants, PA
🇺🇸Austin, Texas, United States
NW Cancer Specialists
🇺🇸Vancouver, Washington, United States
Osceola Cancer Center
🇺🇸Kissimmee, Florida, United States
Texas Cancer Associates, LLP
🇺🇸Dallas, Texas, United States
Cancer Outreach Association, LLC
🇺🇸Abingdon, Virginia, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Oncology Hematology Associates of Northern Pennsylvania, PC
🇺🇸Dubois, Pennsylvania, United States
Ohio Cancer Specialists, Inc.
🇺🇸Mansfield, Ohio, United States
The Gerad Center for Cancer Treatment
🇺🇸Lima, Ohio, United States
Lynchburg Hematology Oncology Clinic, Inc.
🇺🇸Lynchburg, Virginia, United States
Florida Cancer Institute
🇺🇸New Port Richey, Florida, United States
Mid-Florida Hematology & Oncology Centers, P.A.
🇺🇸Orange City, Florida, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Hematology & Oncology of NE Georgia, PC
🇺🇸Athens, Georgia, United States
St. Luke's Mountain States Tumor Institute
🇺🇸Boise, Idaho, United States
Oncology and Hematology Associates of West Broward P.A.
🇺🇸Tamarac, Florida, United States
Hematology Oncology Consultants
🇺🇸Naperville, Illinois, United States
Hematology Oncology Clinic
🇺🇸Baton Rouge, Louisiana, United States
Kalamazoo Hematology and Oncology
🇺🇸Kalamazoo, Michigan, United States
Combined Hematology Oncology Practice of New Jersey
🇺🇸Jersey City, New Jersey, United States
Upstate NY Cancer Research and Education Foundation
🇺🇸Rochester, New York, United States
Westchester Hematology Oncology Associates
🇺🇸Mount Kisco, New York, United States
Lake Norman Hematology/ Oncology Specialists
🇺🇸Mooresville, North Carolina, United States
Blue Ridge Medical Specialists
🇺🇸Bristol, Tennessee, United States
Cascade Cancer Center
🇺🇸Kirkland, Washington, United States
Charleston Cancer Center
🇺🇸Charleston, South Carolina, United States
Consultants in Blood Disorders and Cancer
🇺🇸Louisville, Kentucky, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Little Rock Hematology Oncology Associates
🇺🇸Little Rock, Arkansas, United States
Southbay Oncology Hematology Partners
🇺🇸Campbell, California, United States
Los Palos Oncology and Hematology Center
🇺🇸Salinas, California, United States
Florida Wellcare Alliance
🇺🇸Inverness, Florida, United States
Nassau Hematology Oncology, P.C.
🇺🇸Lake Success, New York, United States
Crystal Run Healthcare
🇺🇸Middletown, New York, United States