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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00091663
• Other study ID #: OSI3199g
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2004
• Last updated: February 28, 2014
• Start date: August 2004
• Est. completion date: August 2005

Study information

• Verified date: February 2014
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-small-cell Lung Carcinoma

Intervention

Drug:
• Tarceva (erlotinib HCl)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation