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Lung CancerPhase 3NCT00091663

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

A Phase 3 study testing Tarceva (erlotinib HCl) in people with Lung Cancer and Non-small-cell Lung Carcinoma, run by Genentech, Inc. at 92 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Non-small-cell Lung Carcinoma
What is being tested?
Tarceva (erlotinib HCl)
How many people
5,000 participants
Where
92 sitesUnited States
Study dates
Aug 2004to Aug 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

92 sites in 1 country.

92 sites in 1 country

United States92 sites

  • Cancer Outreach Association, LLC

    Abingdon, Virginia, 24211

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Annapolis Medical Specialists, LLC

    Annapolis, Maryland, 21401

  • Arlington Fairfax Hematology Oncology, P.C.

    Arlington, Virginia, 22205

  • Northwest Medical Specialists

    Arlington Heights, Illinois, 60005

  • Cancer Care of WNC

    Asheville, North Carolina, 28801

  • Hematology & Oncology of NE Georgia, PC

    Athens, Georgia, 30607

  • Southwest Regional Cancer Center

    Austin, Texas, 78705

  • Lone Star Oncology Consultants, PA

    Austin, Texas, 78759

  • Maryland Hematology/Oncology Associates, PA

    Baltimore, Maryland, 21236

  • Hematology Oncology Clinic

    Baton Rouge, Louisiana, 70808

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Hematology Oncology Associates of Western Suffolk, PC

    Bay Shore, New York, 11706

  • Essex Oncology of North Jersey

    Belleville, New Jersey, 07109

  • Center for Cancer and Blood Disorders, P.C.

    Bethesda, Maryland, 20817-7847

  • Tower Hematology Oncology Medical Group

    Beverly Hills, California, 90211

  • St. Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Blue Ridge Medical Specialists

    Bristol, Tennessee, 37620

  • Southbay Oncology Hematology Partners

    Campbell, California, 95008

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Charleston Cancer Center

    Charleston, South Carolina, 29406

  • The Center for Cancer and Hematologic Disease

    Cherry Hill, New Jersey, 08003

  • The Family Cancer Center

    Collierville, Tennessee, 38017

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina, 29210

  • Hematology Oncology Consultants, Inc.

    Columbus, Ohio, 43235

  • Coastal Bend Oncology Hematology

    Corpus Christi, Texas, 78404

  • Drs. Sambandam & Joseph Associates, Inc.

    Cranston, Rhode Island, 02920

  • Center for Oncology Research and Treatment P. A.

    Dallas, Texas, 75230

  • Texas Cancer Associates, LLP

    Dallas, Texas, 75231

  • Texas Hematology/Oncology Center, P.A.

    Dallas, Texas, 75234

  • Steve Perkins, MD, PA

    Dallas, Texas, 75235

  • Oncology Hematology Associates of Northern Pennsylvania, PC

    DuBois, Pennsylvania, 15801

  • Lee Cancer Clinic

    Fort Myers, Florida, 33919

  • West Michigan Regional Cancer & Blood Center

    Free Soil, Michigan, 49411

  • Gaston Hematology and Oncology

    Gastonia, North Carolina, 28054

  • C. Michael Jones, MD PC

    Germantown, Tennessee, 38138

  • Satish A. Shah, MD, PC

    Gettysburg, Pennsylvania, 17325

  • Palo Verde Hematology/Oncology, Ltd.

    Glendale, Arizona, 85204

  • Kentucky Cancer Clinic

    Hazard, Kentucky, 41701

  • Northwestern Carolina Oncology & Hematology, PA

    Hickory, North Carolina, 28602

  • Comprehensive Cancer Institute

    Huntsville, Alabama, 35801

  • Hematology-Oncology Specialist, Center for Cancer Care

    Huntsville, Alabama, 35801

  • Florida Wellcare Alliance

    Inverness, Florida, 34452

  • Florida Oncology Associates

    Jacksonville, Florida, 32207

  • Combined Hematology Oncology Practice of New Jersey

    Jersey City, New Jersey, 07306

  • McLeod Cancer & Blood Center

    Johnson City, Tennessee, 37604

  • Kalamazoo Hematology and Oncology

    Kalamazoo, Michigan, 49048

  • Cascade Cancer Center

    Kirkland, Washington, 98034

  • Osceola Cancer Center

    Kissimmee, Florida, 34741

  • Louisiana Oncology Associates, PMC

    Lafayette, Louisiana, 70506

  • Nassau Hematology Oncology, P.C.

    Lake Success, New York, 11042

  • Antelope Valley Cancer Center

    Lancaster, California, 93534

  • The Gerad Center for Cancer Treatment

    Lima, Ohio, 45805

  • Little Rock Hematology Oncology Associates

    Little Rock, Arkansas, 72205

  • Consultants in Blood Disorders and Cancer

    Louisville, Kentucky, 40207

  • Lynchburg Hematology Oncology Clinic, Inc.

    Lynchburg, Virginia, 24501

  • Ohio Cancer Specialists, Inc.

    Mansfield, Ohio, 44907

  • Crystal Run Healthcare

    Middletown, New York, 10941

  • Signal Point Hematology/Oncology, Inc.

    Middletown, Ohio, 45042

  • Piedmont Oncology Specialists

    Monroe, North Carolina, 28112

  • Clinical Trials and Research Associates, Inc.

    Montebello, California, 90640

  • Lake Norman Hematology/ Oncology Specialists

    Mooresville, North Carolina, 28117

  • Westchester Hematology Oncology Associates

    Mount Kisco, New York, 10549

  • Hematology Oncology Consultants

    Naperville, Illinois, 60540

  • The Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • Florida Cancer Institute

    New Port Richey, Florida, 34652

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Utah Hematology and Oncology

    Ogden, Utah, 84403

  • Comprehensive Cancer Center

    Oklahoma City, Oklahoma, 73112

  • Mid-Florida Hematology & Oncology Centers, P.A.

    Orange City, Florida, 32763

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Metcare Oncology

    Ormond Beach, Florida, 32174

  • Hematology Oncology Associates

    Pensacola, Florida, 32501

  • Berkshire Hematology Oncology, PC

    Pittsfield, Massachusetts, 01201

  • Cancer and Blood Institute Medical Group

    Rancho Mirage, California, 92270

  • Ministry Medical Group

    Rhinelander, Wisconsin, 54501

  • Upstate NY Cancer Research and Education Foundation

    Rochester, New York, 14623

  • Rutland Regional Medical Center

    Rutland, Vermont, 05701

  • Oncology Care Associates, P.L.L.C.

    Saint Joseph, Michigan, 49085

  • Los Palos Oncology and Hematology Center

    Salinas, California, 93901

  • Maine Center for Cancer Medicine & Blood Disorders

    Scarborough, Maine, 04074

  • Sioux Valley Clinic

    Sioux Falls, South Dakota, 57104

  • Hematology Oncology, PC

    Stamford, Connecticut, 06902

  • Staten Island Medical Group

    Staten Island, New York, 10301

  • Santee Hematology/Oncology

    Sumter, South Carolina, 29150

  • Oncology and Hematology Associates of West Broward P.A.

    Tamarac, Florida, 33321

  • Bay Area Oncology

    Tampa, Florida, 33607

  • Space Coast Medical Associates

    Titusville, Florida, 32796

  • Arizona Hematology Oncology, PC

    Tucson, Arizona, 85704

  • Naveen Gupta, MD, Inc.

    Upland, California, 91786

  • NW Cancer Specialists

    Vancouver, Washington, 98684

  • Cedar Valley Medical Specialists, PC

    Waterloo, Iowa, 50702

Other trials in United States

About this study

Official title: 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.

Being tested
Tarceva (erlotinib HCl)
Keywords
Advanced non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tarceva (erlotinib HCl)Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2004 (estimated)
  2. Study startAug 2004
  3. Study completionAug 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Enrolment
5,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00091663
Sponsor's protocol ID
OSI3199g
Status last verified
Feb 2014
First submitted
15 Sep 2004
Last updated
4 Mar 2014
Results posted
No

Publications

  • 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.

    PubMed 18438878

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tarceva (erlotinib HCl) in people with Lung Cancer and Non-small-cell Lung Carcinoma, run by Genentech, Inc. at 92 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00091663, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.

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