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

Primary Purpose

Lung Cancer, Non-small-cell Lung Carcinoma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tarceva (erlotinib HCl)
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Advanced non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Cancer Institute
  • Hematology-Oncology Specialist, Center for Cancer Care
  • Providence Alaska Medical Center
  • Palo Verde Hematology/Oncology, Ltd.
  • Arizona Hematology Oncology, PC
  • Little Rock Hematology Oncology Associates
  • Tower Hematology Oncology Medical Group
  • Southbay Oncology Hematology Partners
  • Antelope Valley Cancer Center
  • Clinical Trials and Research Associates, Inc.
  • Cancer and Blood Institute Medical Group
  • Los Palos Oncology and Hematology Center
  • Naveen Gupta, MD, Inc.
  • Hematology Oncology, PC
  • Lee Cancer Clinic
  • Florida Wellcare Alliance
  • Florida Oncology Associates
  • Osceola Cancer Center
  • Florida Cancer Institute
  • Ocala Oncology Center
  • Mid-Florida Hematology & Oncology Centers, P.A.
  • Florida Hospital Cancer Institute
  • Metcare Oncology
  • Hematology Oncology Associates
  • Oncology and Hematology Associates of West Broward P.A.
  • Bay Area Oncology
  • Space Coast Medical Associates
  • Hematology & Oncology of NE Georgia, PC
  • St. Luke's Mountain States Tumor Institute
  • Northwest Medical Specialists
  • Hematology Oncology Consultants
  • Cedar Valley Medical Specialists, PC
  • Kentucky Cancer Clinic
  • Consultants in Blood Disorders and Cancer
  • Hematology Oncology Clinic
  • Mary Bird Perkins Cancer Center
  • Louisiana Oncology Associates, PMC
  • Maine Center for Cancer Medicine & Blood Disorders
  • Annapolis Medical Specialists, LLC
  • Maryland Hematology/Oncology Associates, PA
  • Center for Cancer and Blood Disorders, P.C.
  • Berkshire Hematology Oncology, PC
  • West Michigan Regional Cancer & Blood Center
  • Kalamazoo Hematology and Oncology
  • Oncology Care Associates, P.L.L.C.
  • Essex Oncology of North Jersey
  • The Center for Cancer and Hematologic Disease
  • Combined Hematology Oncology Practice of New Jersey
  • Hematology Oncology Associates of Western Suffolk, PC
  • Nassau Hematology Oncology, P.C.
  • Crystal Run Healthcare
  • Westchester Hematology Oncology Associates
  • Upstate NY Cancer Research and Education Foundation
  • Staten Island Medical Group
  • Cancer Care of WNC
  • Gaston Hematology and Oncology
  • Northwestern Carolina Oncology & Hematology, PA
  • Piedmont Oncology Specialists
  • Lake Norman Hematology/ Oncology Specialists
  • Gabrail Cancer Center
  • Hematology Oncology Consultants, Inc.
  • The Gerad Center for Cancer Treatment
  • Ohio Cancer Specialists, Inc.
  • Signal Point Hematology/Oncology, Inc.
  • Comprehensive Cancer Center
  • Oncology Hematology Associates of Northern Pennsylvania, PC
  • Satish A. Shah, MD, PC
  • Drs. Sambandam & Joseph Associates, Inc.
  • Charleston Cancer Center
  • South Carolina Oncology Associates, PA
  • Santee Hematology/Oncology
  • Sioux Valley Clinic
  • Blue Ridge Medical Specialists
  • The Family Cancer Center
  • C. Michael Jones, MD PC
  • McLeod Cancer & Blood Center
  • The Sarah Cannon Cancer Center
  • Southwest Regional Cancer Center
  • Lone Star Oncology Consultants, PA
  • Coastal Bend Oncology Hematology
  • Center for Oncology Research and Treatment P. A.
  • Texas Cancer Associates, LLP
  • Texas Hematology/Oncology Center, P.A.
  • Steve Perkins, MD, PA
  • Utah Hematology and Oncology
  • Rutland Regional Medical Center
  • Cancer Outreach Association, LLC
  • Arlington Fairfax Hematology Oncology, P.C.
  • Lynchburg Hematology Oncology Clinic, Inc.
  • Cascade Cancer Center
  • NW Cancer Specialists
  • Ministry Medical Group

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 15, 2004
Last Updated
February 28, 2014
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00091663
Brief Title
A Study to Evaluate Tarceva in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Official Title
A Multicenter, Open-Label, Phase IIIb Trial of Tarceva (Erlotinib Hydrochloride) in Patients With Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Non-small-cell Lung Carcinoma
Keywords
Advanced non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
5000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tarceva (erlotinib HCl)

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
18438878
Citation
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.
Results Reference
result

Learn more about this trial

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

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