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

February 28, 2014 updated by: Genentech, Inc.

A Multicenter, Open-Label, Phase IIIb Trial of Tarceva (Erlotinib Hydrochloride) in Patients With Advanced Non-Small Cell Lung Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

5000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

September 15, 2004

First Submitted That Met QC Criteria

September 15, 2004

First Posted (Estimate)

September 16, 2004

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

February 28, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSI3199g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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