A Study to Evaluate Tarceva in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00091663
First received: September 15, 2004
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Non-small-cell Lung Carcinoma
Drug: Tarceva (erlotinib HCl)
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Phase IIIb Trial of Tarceva (Erlotinib Hydrochloride) in Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Genentech:

Estimated Enrollment: 5000
Study Start Date: August 2004
Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091663

  Hide Study Locations
Locations
United States, Alabama
Hematology-Oncology Specialist, Center for Cancer Care
Huntsville, Alabama, United States, 35801
Comprehensive Cancer Institute
Huntsville, Alabama, United States, 35801
United States, Alaska
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, Arizona
Palo Verde Hematology/Oncology, Ltd.
Glendale, Arizona, United States, 85204
Arizona Hematology Oncology, PC
Tucson, Arizona, United States, 85704
United States, Arkansas
Little Rock Hematology Oncology Associates
Little Rock, Arkansas, United States, 72205
United States, California
Tower Hematology Oncology Medical Group
Beverly Hills, California, United States, 90211
Southbay Oncology Hematology Partners
Campbell, California, United States, 95008
Antelope Valley Cancer Center
Lancaster, California, United States, 93534
Clinical Trials and Research Associates, Inc.
Montebello, California, United States, 90640
Cancer and Blood Institute Medical Group
Rancho Mirage, California, United States, 92270
Los Palos Oncology and Hematology Center
Salinas, California, United States, 93901
Naveen Gupta, MD, Inc.
Upland, California, United States, 91786
United States, Connecticut
Hematology Oncology, PC
Stamford, Connecticut, United States, 06902
United States, Florida
Lee Cancer Clinic
Fort Myers, Florida, United States, 33919
Florida Wellcare Alliance
Inverness, Florida, United States, 34452
Florida Oncology Associates
Jacksonville, Florida, United States, 32207
Osceola Cancer Center
Kissimmee, Florida, United States, 34741
Florida Cancer Institute
New Port Richey, Florida, United States, 34652
Ocala Oncology Center
Ocala, Florida, United States, 34474
Mid-Florida Hematology & Oncology Centers, P.A.
Orange City, Florida, United States, 32763
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Metcare Oncology
Ormond Beach, Florida, United States, 32174
Hematology Oncology Associates
Pensacola, Florida, United States, 32501
Oncology and Hematology Associates of West Broward P.A.
Tamarac, Florida, United States, 33321
Bay Area Oncology
Tampa, Florida, United States, 33607
Space Coast Medical Associates
Titusville, Florida, United States, 32796
United States, Georgia
Hematology & Oncology of NE Georgia, PC
Athens, Georgia, United States, 30607
United States, Idaho
St. Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
United States, Illinois
Northwest Medical Specialists
Arlington Heights, Illinois, United States, 60005
Hematology Oncology Consultants
Naperville, Illinois, United States, 60540
United States, Iowa
Cedar Valley Medical Specialists, PC
Waterloo, Iowa, United States, 50702
United States, Kentucky
Kentucky Cancer Clinic
Hazard, Kentucky, United States, 41701
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Hematology Oncology Clinic
Baton Rouge, Louisiana, United States, 70808
Louisiana Oncology Associates, PMC
Lafayette, Louisiana, United States, 70506
United States, Maine
Maine Center for Cancer Medicine & Blood Disorders
Scarborough, Maine, United States, 04074
United States, Maryland
Annapolis Medical Specialists, LLC
Annapolis, Maryland, United States, 21401
Maryland Hematology/Oncology Associates, PA
Baltimore, Maryland, United States, 21236
Center for Cancer and Blood Disorders, P.C.
Bethesda, Maryland, United States, 20817-7847
United States, Massachusetts
Berkshire Hematology Oncology, PC
Pittsfield, Massachusetts, United States, 01201
United States, Michigan
West Michigan Regional Cancer & Blood Center
Free Soil, Michigan, United States, 49411
Kalamazoo Hematology and Oncology
Kalamazoo, Michigan, United States, 49048
Oncology Care Associates, P.L.L.C.
St. Joseph, Michigan, United States, 49085
United States, New Jersey
Essex Oncology of North Jersey
Belleville, New Jersey, United States, 07109
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States, 08003
Combined Hematology Oncology Practice of New Jersey
Jersey City, New Jersey, United States, 07306
United States, New York
Hematology Oncology Associates of Western Suffolk, PC
Bay Shore, New York, United States, 11706
Nassau Hematology Oncology, P.C.
Lake Success, New York, United States, 11042
Crystal Run Healthcare
Middletown, New York, United States, 10941
Westchester Hematology Oncology Associates
Mount Kisco, New York, United States, 10549
Upstate NY Cancer Research and Education Foundation
Rochester, New York, United States, 14623
Staten Island Medical Group
Staten Island, New York, United States, 10301
United States, North Carolina
Cancer Care of WNC
Asheville, North Carolina, United States, 28801
Gaston Hematology and Oncology
Gastonia, North Carolina, United States, 28054
Northwestern Carolina Oncology & Hematology, PA
Hickory, North Carolina, United States, 28602
Piedmont Oncology Specialists
Monroe, North Carolina, United States, 28112
Lake Norman Hematology/ Oncology Specialists
Mooresville, North Carolina, United States, 28117
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Hematology Oncology Consultants, Inc.
Columbus, Ohio, United States, 43235
The Gerad Center for Cancer Treatment
Lima, Ohio, United States, 45805
Ohio Cancer Specialists, Inc.
Mansfield, Ohio, United States, 44907
Signal Point Hematology/Oncology, Inc.
Middletown, Ohio, United States, 45042
United States, Oklahoma
Comprehensive Cancer Center
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Oncology Hematology Associates of Northern Pennsylvania, PC
Dubois, Pennsylvania, United States, 15801
Satish A. Shah, MD, PC
Gettysburg, Pennsylvania, United States, 17325
United States, Rhode Island
Drs. Sambandam & Joseph Associates, Inc.
Cranston, Rhode Island, United States, 02920
United States, South Carolina
Charleston Cancer Center
Charleston, South Carolina, United States, 29406
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States, 29210
Santee Hematology/Oncology
Sumter, South Carolina, United States, 29150
United States, South Dakota
Sioux Valley Clinic
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Blue Ridge Medical Specialists
Bristol, Tennessee, United States, 37620
The Family Cancer Center
Collierville, Tennessee, United States, 38017
C. Michael Jones, MD PC
Germantown, Tennessee, United States, 38138
McLeod Cancer & Blood Center
Johnson City, Tennessee, United States, 37604
The Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
United States, Texas
Lone Star Oncology Consultants, PA
Austin, Texas, United States, 78759
Southwest Regional Cancer Center
Austin, Texas, United States, 78705
Coastal Bend Oncology Hematology
Corpus Christi, Texas, United States, 78404
Center for Oncology Research and Treatment P. A.
Dallas, Texas, United States, 75230
Texas Cancer Associates, LLP
Dallas, Texas, United States, 75231
Texas Hematology/Oncology Center, P.A.
Dallas, Texas, United States, 75234
Steve Perkins, MD, PA
Dallas, Texas, United States, 75235
United States, Utah
Utah Hematology and Oncology
Ogden, Utah, United States, 84403
United States, Vermont
Rutland Regional Medical Center
Rutland, Vermont, United States, 05701
United States, Virginia
Cancer Outreach Association, LLC
Abingdon, Virginia, United States, 24211
Arlington Fairfax Hematology Oncology, P.C.
Arlington, Virginia, United States, 22205
Lynchburg Hematology Oncology Clinic, Inc.
Lynchburg, Virginia, United States, 24501
United States, Washington
Cascade Cancer Center
Kirkland, Washington, United States, 98034
NW Cancer Specialists
Vancouver, Washington, United States, 98684
United States, Wisconsin
Ministry Medical Group
Rhinelander, Wisconsin, United States, 54501
Sponsors and Collaborators
Genentech
  More Information

Publications:
Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00091663     History of Changes
Other Study ID Numbers: OSI3199g
Study First Received: September 15, 2004
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Advanced non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014