Clinical trial NCT00294762: Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC
Official title: A Phase 2 Randomized Study of Tarceva (Erlotinib) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With Newly Diagnosed Advanced Non-small Cell Lung Cancer Who Have Tumors With EGFR Protein Overexpression and/or Increased EGFR Gene Copy Numbers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: NSCLC
Erlotinib
Tarceva
Lung Cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-02-22
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18
* Histologically or cytologically documented non-small cell lung cancer (NSCLC)
* Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2
* Radiologically measurable or evaluable disease No prior chemotherapy
* 1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening
* Tumor tissue block or fine needle aspirate

Exclusion Criteria:

* Any concurrent anticancer therapy or radiation
* Other active malignancy
* Uncontrolled brain metastases
* GI abnormalities
* Severe abnormalities of the cornea
* Significant cardiac disease
* Active infection

Primary outcomes:
measure: 6-month Progression-free Survival
timeFrame: 6 months after first dose
Secondary outcomes:
measure: Progression-free Survival
timeFrame: Until time of disease progression, as assessed every 21 days (maximum 28.8 months)
measure: Overall Survival at 12 Months
timeFrame: 12 months from 1st dose
measure: Overall Survival
timeFrame: From first study treatment until time of death (maximum 29.0 months)
measure: Best Tumor Response
timeFrame: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months)
measure: Duration of Tumor Response
timeFrame: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months).
Other outcomes:
Locations:
city: Alhambra
country: United States
facility: Central Hematology Oncology Medical Group Inc.
state: California
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center(Part of TORI network)
state: California
city: Concord
country: United States
facility: Bay Area Cancer Research Group
state: California
city: Fullerton
country: United States
facility: Virginia K. Crosson Cancer Center
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Northridge
country: United States
facility: North Valley Hematology/Oncology Medical GroupThe Thomas and Dorothy Leavey Cancer Center
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology-Oncology Specialists
state: California
city: Pomona
country: United States
facility: Wilshire Oncology Medical GroupThe Robert and Beverly Lewis Family Cancer Care Center
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates Medical Group, Inc.
state: California
city: Santa Barbara
country: United States
facility: Sansum Santa Barbara Medical Foundation Clinic
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Hematology Oncology Medical Group, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer CenterResearch Department
state: Colorado
city: Norwich
country: United States
facility: Eastern Connecticut Hematology and Oncology Associates
state: Connecticut
city: Orlando
country: United States
facility: MD Anderson Cancer Ctr - Orlando
state: Florida
city: Tampa
country: United States
facility: Gulfcoast Oncology Associates
state: Florida
city: Lawrenceville
country: United States
facility: Suburban Hematology-Oncology Associates
state: Georgia
city: Macon
country: United States
facility: Central Georgia Cancer Care, P.C.
state: Georgia
city: Chicago
country: United States
facility: Rush-Presbyterian-St.Luke's Med Ctr
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Louisville
country: United States
facility: Norton Healthcare, Inc.
state: Kentucky
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Minneapolis
country: United States
facility: Univ. of Minnesota Cancer Center
state: Minnesota
city: Billings
country: United States
facility: Hematology Oncology Centers of Northern Rockies Research
state: Montana
city: Omaha
country: United States
facility: Alegent Healthcare
state: Nebraska
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Mount Holly
country: United States
facility: Hematology-Oncology Associates, SJ, PA - Virtua Health
state: New Jersey
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pottsville
country: United States
facility: Pottsville Cancer Clinic
state: Pennsylvania
city: Memphis
country: United States
facility: Boston Baskin Cancer Groupd/b/a U. of Tennessee Cancer Inst.
state: Tennessee
city: Memphis
country: United States
facility: The West Cancer Clinic
state: Tennessee
city: Memphis
country: United States
facility: ACORN
state: Tennessee
city: Houston
country: United States
facility: University of Texas M.D. Anderson Cancer Center
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Chesapeake
country: United States
facility: Cancer Specialists of Tidewater, Ltd.
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Cambridge
country: United Kingdom
facility: CR UK
city: Cambridge
country: United Kingdom
facility: Peterborough District Hospital
city: Glasgow
country: United Kingdom
facility: Beatson Oncology Centre
city: Middlesex
country: United Kingdom
facility: Mount Vernon Hospital
Study officials:
References: