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
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung
Both
Carcinoma, Non-Small-Cell Lung
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 Center | Seattle, Washington 98109 |
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| Fletcher Allen Health Care | Burlington, Vermont 05401 |
| Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
| Eastern Connecticut Hematology and Oncology Associates | Norwich, Connecticut 06360 |
| Pacific Shores Medical Group | Long Beach, California 90813 |
| University of Chicago Medical Center | Chicago, Illinois 60637 |
| UCLA Medical Center | Los Angeles, California 90095-7059 |
| Providence Portland Medical Center | Portland, Oregon 97213-3635 |
| University of Texas M.D. Anderson Cancer Center | Houston, Texas 77030 |
| Norton Healthcare, Inc. | Louisville, Kentucky 40202 |
| Virginia K. Crosson Cancer Center | Fullerton, California 92835 |
| Ventura County Hematology-Oncology Specialists | Oxnard, 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 Group | Concord, California 94520 |
| Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Suburban Hematology-Oncology Associates | Lawrenceville, Georgia 30045 |
| The West Cancer Clinic | Memphis, Tennessee 38120 |
| Gulfcoast Oncology Associates | St. Petersburg, Florida 33705 |
| Central Georgia Cancer Care, P.C. | Macon, Georgia 31201 |
| Sansum Santa Barbara Medical Foundation Clinic | Santa 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 Center | Northridge, California 91325 |
| Wilshire Oncology Medical GroupThe Robert and Beverly Lewis Family Cancer Care Center | Pomona, California 91767 |
| Rocky Mountain Cancer CenterResearch Department | Denver, Colorado 80218 |
| MD Anderson Cancer Ctr - Orlando | Orlando, Florida 32806 |
| Rush-Presbyterian-St.Luke's Med Ctr | Chicago, Illinois 60612 |
| Univ. of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
| Hematology Oncology Centers of Northern Rockies Research | Billings, Montana 59101 |
| Alegent Healthcare | Omaha, Nebraska 68124 |
| Hematology-Oncology Associates, SJ, PA - Virtua Health | Mount Holly, New Jersey 08060 |
| Pottsville Cancer Clinic | Pottsville, Pennsylvania 17901 |
| Boston Baskin Cancer Groupd/b/a U. of Tennessee Cancer Inst. | Memphis, Tennessee 38104 |
| ACORN | Memphis, Tennessee 38138 |
| Cancer Specialists of Tidewater, Ltd. | Chesapeake, Virginia 23320 |
