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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6-month Progression-free Survival

Outcome Description:

Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.

Outcome Time Frame:

6 months after first dose

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

OSI-774-203

NCT ID:

NCT00294762

Start Date:

January 2006

Completion Date:

March 2009

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • NSCLC
  • Erlotinib
  • Tarceva
  • Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Colorado Cancer CenterDenver, Colorado  80262
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Fletcher Allen Health CareBurlington, Vermont  05401
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut  06360
Pacific Shores Medical GroupLong Beach, California  90813
University of Chicago Medical CenterChicago, Illinois  60637
UCLA Medical CenterLos Angeles, California  90095-7059
Providence Portland Medical CenterPortland, Oregon  97213-3635
University of Texas M.D. Anderson Cancer CenterHouston, Texas  77030
Norton Healthcare, Inc.Louisville, Kentucky  40202
Virginia K. Crosson Cancer CenterFullerton, California  92835
Ventura County Hematology-Oncology SpecialistsOxnard, California  93030
Santa Barbara Hematology Oncology Medical Group, Inc.Santa Barbara, California  93105
Cancer Care Associates Medical Group, Inc.Torrance, California  90505
Bay Area Cancer Research GroupConcord, California  94520
Karmanos Cancer InstituteDetroit, Michigan  48201
Suburban Hematology-Oncology AssociatesLawrenceville, Georgia  30045
The West Cancer ClinicMemphis, Tennessee  38120
Gulfcoast Oncology AssociatesSt. Petersburg, Florida  33705
Central Georgia Cancer Care, P.C.Macon, Georgia  31201
Sansum Santa Barbara Medical Foundation ClinicSanta Barbara, California  93105
Central Hematology Oncology Medical Group Inc.Alhambra, California  91801
Comprehensive Blood and Cancer Center(Part of TORI network)Bakersfield, California  93309
North Valley Hematology/Oncology Medical GroupThe Thomas and Dorothy Leavey Cancer CenterNorthridge, California  91325
Wilshire Oncology Medical GroupThe Robert and Beverly Lewis Family Cancer Care CenterPomona, California  91767
Rocky Mountain Cancer CenterResearch DepartmentDenver, Colorado  80218
MD Anderson Cancer Ctr - OrlandoOrlando, Florida  32806
Rush-Presbyterian-St.Luke's Med CtrChicago, Illinois  60612
Univ. of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Hematology Oncology Centers of Northern Rockies ResearchBillings, Montana  59101
Alegent HealthcareOmaha, Nebraska  68124
Hematology-Oncology Associates, SJ, PA - Virtua HealthMount Holly, New Jersey  08060
Pottsville Cancer ClinicPottsville, Pennsylvania  17901
Boston Baskin Cancer Groupd/b/a U. of Tennessee Cancer Inst.Memphis, Tennessee  38104
ACORNMemphis, Tennessee  38138
Cancer Specialists of Tidewater, Ltd.Chesapeake, Virginia  23320