Clinical trial NCT00091663: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Non-small-cell Lung Carcinoma
Keywords: Advanced non-small cell lung cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2004-09-16
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Comprehensive Cancer Institute
state: Alabama
city: Huntsville
country: United States
facility: Hematology-Oncology Specialist, Center for Cancer Care
state: Alabama
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Glendale
country: United States
facility: Palo Verde Hematology/Oncology, Ltd.
state: Arizona
city: Tucson
country: United States
facility: Arizona Hematology Oncology, PC
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Hematology Oncology Associates
state: Arkansas
city: Beverly Hills
country: United States
facility: Tower Hematology Oncology Medical Group
state: California
city: Campbell
country: United States
facility: Southbay Oncology Hematology Partners
state: California
city: Lancaster
country: United States
facility: Antelope Valley Cancer Center
state: California
city: Montebello
country: United States
facility: Clinical Trials and Research Associates, Inc.
state: California
city: Rancho Mirage
country: United States
facility: Cancer and Blood Institute Medical Group
state: California
city: Salinas
country: United States
facility: Los Palos Oncology and Hematology Center
state: California
city: Upland
country: United States
facility: Naveen Gupta, MD, Inc.
state: California
city: Stamford
country: United States
facility: Hematology Oncology, PC
state: Connecticut
city: Fort Myers
country: United States
facility: Lee Cancer Clinic
state: Florida
city: Inverness
country: United States
facility: Florida Wellcare Alliance
state: Florida
city: Jacksonville
country: United States
facility: Florida Oncology Associates
state: Florida
city: Kissimmee
country: United States
facility: Osceola Cancer Center
state: Florida
city: New Port Richey
country: United States
facility: Florida Cancer Institute
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Orange City
country: United States
facility: Mid-Florida Hematology & Oncology Centers, P.A.
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Ormond Beach
country: United States
facility: Metcare Oncology
state: Florida
city: Pensacola
country: United States
facility: Hematology Oncology Associates
state: Florida
city: Tamarac
country: United States
facility: Oncology and Hematology Associates of West Broward P.A.
state: Florida
city: Tampa
country: United States
facility: Bay Area Oncology
state: Florida
city: Titusville
country: United States
facility: Space Coast Medical Associates
state: Florida
city: Athens
country: United States
facility: Hematology & Oncology of NE Georgia, PC
state: Georgia
city: Boise
country: United States
facility: St. Luke's Mountain States Tumor Institute
state: Idaho
city: Arlington Heights
country: United States
facility: Northwest Medical Specialists
state: Illinois
city: Naperville
country: United States
facility: Hematology Oncology Consultants
state: Illinois
city: Waterloo
country: United States
facility: Cedar Valley Medical Specialists, PC
state: Iowa
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Louisville
country: United States
facility: Consultants in Blood Disorders and Cancer
state: Kentucky
city: Baton Rouge
country: United States
facility: Hematology Oncology Clinic
state: Louisiana
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: Lafayette
country: United States
facility: Louisiana Oncology Associates, PMC
state: Louisiana
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine & Blood Disorders
state: Maine
city: Annapolis
country: United States
facility: Annapolis Medical Specialists, LLC
state: Maryland
city: Baltimore
country: United States
facility: Maryland Hematology/Oncology Associates, PA
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders, P.C.
state: Maryland
city: Pittsfield
country: United States
facility: Berkshire Hematology Oncology, PC
state: Massachusetts
city: Free Soil
country: United States
facility: West Michigan Regional Cancer & Blood Center
state: Michigan
city: Kalamazoo
country: United States
facility: Kalamazoo Hematology and Oncology
state: Michigan
city: St. Joseph
country: United States
facility: Oncology Care Associates, P.L.L.C.
state: Michigan
city: Belleville
country: United States
facility: Essex Oncology of North Jersey
state: New Jersey
city: Cherry Hill
country: United States
facility: The Center for Cancer and Hematologic Disease
state: New Jersey
city: Jersey City
country: United States
facility: Combined Hematology Oncology Practice of New Jersey
state: New Jersey
city: Bay Shore
country: United States
facility: Hematology Oncology Associates of Western Suffolk, PC
state: New York
city: Lake Success
country: United States
facility: Nassau Hematology Oncology, P.C.
state: New York
city: Middletown
country: United States
facility: Crystal Run Healthcare
state: New York
city: Mount Kisco
country: United States
facility: Westchester Hematology Oncology Associates
state: New York
city: Rochester
country: United States
facility: Upstate NY Cancer Research and Education Foundation
state: New York
city: Staten Island
country: United States
facility: Staten Island Medical Group
state: New York
city: Asheville
country: United States
facility: Cancer Care of WNC
state: North Carolina
city: Gastonia
country: United States
facility: Gaston Hematology and Oncology
state: North Carolina
city: Hickory
country: United States
facility: Northwestern Carolina Oncology & Hematology, PA
state: North Carolina
city: Monroe
country: United States
facility: Piedmont Oncology Specialists
state: North Carolina
city: Mooresville
country: United States
facility: Lake Norman Hematology/ Oncology Specialists
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Hematology Oncology Consultants, Inc.
state: Ohio
city: Lima
country: United States
facility: The Gerad Center for Cancer Treatment
state: Ohio
city: Mansfield
country: United States
facility: Ohio Cancer Specialists, Inc.
state: Ohio
city: Middletown
country: United States
facility: Signal Point Hematology/Oncology, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Comprehensive Cancer Center
state: Oklahoma
city: Dubois
country: United States
facility: Oncology Hematology Associates of Northern Pennsylvania, PC
state: Pennsylvania
city: Gettysburg
country: United States
facility: Satish A. Shah, MD, PC
state: Pennsylvania
city: Cranston
country: United States
facility: Drs. Sambandam & Joseph Associates, Inc.
state: Rhode Island
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Oncology Associates, PA
state: South Carolina
city: Sumter
country: United States
facility: Santee Hematology/Oncology
state: South Carolina
city: Sioux Falls
country: United States
facility: Sioux Valley Clinic
state: South Dakota
city: Bristol
country: United States
facility: Blue Ridge Medical Specialists
state: Tennessee
city: Collierville
country: United States
facility: The Family Cancer Center
state: Tennessee
city: Germantown
country: United States
facility: C. Michael Jones, MD PC
state: Tennessee
city: Johnson City
country: United States
facility: McLeod Cancer & Blood Center
state: Tennessee
city: Nashville
country: United States
facility: The Sarah Cannon Cancer Center
state: Tennessee
city: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
city: Austin
country: United States
facility: Lone Star Oncology Consultants, PA
state: Texas
city: Corpus Christi
country: United States
facility: Coastal Bend Oncology Hematology
state: Texas
city: Dallas
country: United States
facility: Center for Oncology Research and Treatment P. A.
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Associates, LLP
state: Texas
city: Dallas
country: United States
facility: Texas Hematology/Oncology Center, P.A.
state: Texas
city: Dallas
country: United States
facility: Steve Perkins, MD, PA
state: Texas
city: Ogden
country: United States
facility: Utah Hematology and Oncology
state: Utah
city: Rutland
country: United States
facility: Rutland Regional Medical Center
state: Vermont
city: Abingdon
country: United States
facility: Cancer Outreach Association, LLC
state: Virginia
city: Arlington
country: United States
facility: Arlington Fairfax Hematology Oncology, P.C.
state: Virginia
city: Lynchburg
country: United States
facility: Lynchburg Hematology Oncology Clinic, Inc.
state: Virginia
city: Kirkland
country: United States
facility: Cascade Cancer Center
state: Washington
city: Vancouver
country: United States
facility: NW Cancer Specialists
state: Washington
city: Rhinelander
country: United States
facility: Ministry Medical Group
state: Wisconsin
Study officials:
References:
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.