A Study to Evaluate Tarceva in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
A Multicenter, Open-Label, Phase IIIb Trial of Tarceva (Erlotinib Hydrochloride) in Patients With Advanced Non-Small Cell Lung Cancer
1 other identifier
interventional
5,000
1 country
92
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 lung-cancer
Started Aug 2004
Shorter than P25 for phase_3 lung-cancer
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 15, 2004
CompletedFirst Posted
Study publicly available on registry
September 16, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedMarch 4, 2014
February 1, 2014
September 15, 2004
February 28, 2014
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (92)
Comprehensive Cancer Institute
Huntsville, Alabama, 35801, United States
Hematology-Oncology Specialist, Center for Cancer Care
Huntsville, Alabama, 35801, United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
Palo Verde Hematology/Oncology, Ltd.
Glendale, Arizona, 85204, United States
Arizona Hematology Oncology, PC
Tucson, Arizona, 85704, United States
Little Rock Hematology Oncology Associates
Little Rock, Arkansas, 72205, United States
Tower Hematology Oncology Medical Group
Beverly Hills, California, 90211, United States
Southbay Oncology Hematology Partners
Campbell, California, 95008, United States
Antelope Valley Cancer Center
Lancaster, California, 93534, United States
Clinical Trials and Research Associates, Inc.
Montebello, California, 90640, United States
Cancer and Blood Institute Medical Group
Rancho Mirage, California, 92270, United States
Los Palos Oncology and Hematology Center
Salinas, California, 93901, United States
Naveen Gupta, MD, Inc.
Upland, California, 91786, United States
Hematology Oncology, PC
Stamford, Connecticut, 06902, United States
Lee Cancer Clinic
Fort Myers, Florida, 33919, United States
Florida Wellcare Alliance
Inverness, Florida, 34452, United States
Florida Oncology Associates
Jacksonville, Florida, 32207, United States
Osceola Cancer Center
Kissimmee, Florida, 34741, United States
Florida Cancer Institute
New Port Richey, Florida, 34652, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
Mid-Florida Hematology & Oncology Centers, P.A.
Orange City, Florida, 32763, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Metcare Oncology
Ormond Beach, Florida, 32174, United States
Hematology Oncology Associates
Pensacola, Florida, 32501, United States
Oncology and Hematology Associates of West Broward P.A.
Tamarac, Florida, 33321, United States
Bay Area Oncology
Tampa, Florida, 33607, United States
Space Coast Medical Associates
Titusville, Florida, 32796, United States
Hematology & Oncology of NE Georgia, PC
Athens, Georgia, 30607, United States
St. Luke's Mountain States Tumor Institute
Boise, Idaho, 83712, United States
Northwest Medical Specialists
Arlington Heights, Illinois, 60005, United States
Hematology Oncology Consultants
Naperville, Illinois, 60540, United States
Cedar Valley Medical Specialists, PC
Waterloo, Iowa, 50702, United States
Kentucky Cancer Clinic
Hazard, Kentucky, 41701, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, 70808, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Louisiana Oncology Associates, PMC
Lafayette, Louisiana, 70506, United States
Maine Center for Cancer Medicine & Blood Disorders
Scarborough, Maine, 04074, United States
Annapolis Medical Specialists, LLC
Annapolis, Maryland, 21401, United States
Maryland Hematology/Oncology Associates, PA
Baltimore, Maryland, 21236, United States
Center for Cancer and Blood Disorders, P.C.
Bethesda, Maryland, 20817-7847, United States
Berkshire Hematology Oncology, PC
Pittsfield, Massachusetts, 01201, United States
West Michigan Regional Cancer & Blood Center
Free Soil, Michigan, 49411, United States
Kalamazoo Hematology and Oncology
Kalamazoo, Michigan, 49048, United States
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, 49085, United States
Essex Oncology of North Jersey
Belleville, New Jersey, 07109, United States
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003, United States
Combined Hematology Oncology Practice of New Jersey
Jersey City, New Jersey, 07306, United States
Hematology Oncology Associates of Western Suffolk, PC
Bay Shore, New York, 11706, United States
Nassau Hematology Oncology, P.C.
Lake Success, New York, 11042, United States
Crystal Run Healthcare
Middletown, New York, 10941, United States
Westchester Hematology Oncology Associates
Mount Kisco, New York, 10549, United States
Upstate NY Cancer Research and Education Foundation
Rochester, New York, 14623, United States
Staten Island Medical Group
Staten Island, New York, 10301, United States
Cancer Care of WNC
Asheville, North Carolina, 28801, United States
Gaston Hematology and Oncology
Gastonia, North Carolina, 28054, United States
Northwestern Carolina Oncology & Hematology, PA
Hickory, North Carolina, 28602, United States
Piedmont Oncology Specialists
Monroe, North Carolina, 28112, United States
Lake Norman Hematology/ Oncology Specialists
Mooresville, North Carolina, 28117, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Hematology Oncology Consultants, Inc.
Columbus, Ohio, 43235, United States
The Gerad Center for Cancer Treatment
Lima, Ohio, 45805, United States
Ohio Cancer Specialists, Inc.
Mansfield, Ohio, 44907, United States
Signal Point Hematology/Oncology, Inc.
Middletown, Ohio, 45042, United States
Comprehensive Cancer Center
Oklahoma City, Oklahoma, 73112, United States
Oncology Hematology Associates of Northern Pennsylvania, PC
DuBois, Pennsylvania, 15801, United States
Satish A. Shah, MD, PC
Gettysburg, Pennsylvania, 17325, United States
Drs. Sambandam & Joseph Associates, Inc.
Cranston, Rhode Island, 02920, United States
Charleston Cancer Center
Charleston, South Carolina, 29406, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, 29210, United States
Santee Hematology/Oncology
Sumter, South Carolina, 29150, United States
Sioux Valley Clinic
Sioux Falls, South Dakota, 57104, United States
Blue Ridge Medical Specialists
Bristol, Tennessee, 37620, United States
The Family Cancer Center
Collierville, Tennessee, 38017, United States
C. Michael Jones, MD PC
Germantown, Tennessee, 38138, United States
McLeod Cancer & Blood Center
Johnson City, Tennessee, 37604, United States
The Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
Southwest Regional Cancer Center
Austin, Texas, 78705, United States
Lone Star Oncology Consultants, PA
Austin, Texas, 78759, United States
Coastal Bend Oncology Hematology
Corpus Christi, Texas, 78404, United States
Center for Oncology Research and Treatment P. A.
Dallas, Texas, 75230, United States
Texas Cancer Associates, LLP
Dallas, Texas, 75231, United States
Texas Hematology/Oncology Center, P.A.
Dallas, Texas, 75234, United States
Steve Perkins, MD, PA
Dallas, Texas, 75235, United States
Utah Hematology and Oncology
Ogden, Utah, 84403, United States
Rutland Regional Medical Center
Rutland, Vermont, 05701, United States
Cancer Outreach Association, LLC
Abingdon, Virginia, 24211, United States
Arlington Fairfax Hematology Oncology, P.C.
Arlington, Virginia, 22205, United States
Lynchburg Hematology Oncology Clinic, Inc.
Lynchburg, Virginia, 24501, United States
Cascade Cancer Center
Kirkland, Washington, 98034, United States
NW Cancer Specialists
Vancouver, Washington, 98684, United States
Ministry Medical Group
Rhinelander, Wisconsin, 54501, United States
Related Publications (1)
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.
PMID: 18438878RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2004
First Posted
September 16, 2004
Study Start
August 1, 2004
Study Completion
August 1, 2005
Last Updated
March 4, 2014
Record last verified: 2014-02