Randomized Double-Blind Placebo Controlled Phase II Trial Evaluating Erlotinib in Non-Smoking Patients With (Bevacizumab-Eligible and Ineligible) Advanced Non-Small Cell Lung Cancer (NSCLC)
PRIMARY OBJECTIVES:
I. To evaluate the progression-free survival (PFS) of non-smokers with advanced non-small
cell lung cancer randomized to receive treatment with standard care (carboplatin and
paclitaxel with or without bevacizumab) or standard care in combination with erlotinib
hydrochloride.
SECONDARY OBJECTIVES:
I. To evaluate the overall survival of these patients. II. To evaluate the response rate in
these patients. III. To evaluate the relative toxicity of these regimens in these patients.
IV. To determine the frequency of EGFR and Kras mutations in these patients and correlate
mutation status with response rate and PFS.
V. To obtain blood and tissue specimens for further marker-based exploratory analyses
regarding EGFR inhibitors.
VI. To evaluate EGFR positivity by FISH as a predictor of improved PFS in patients treated
with erlotinib hydrochloride.
OUTLINE: This is a multicenter study. Patients are stratified according to gender and
eligibility for bevacizumab therapy (ineligible vs eligible and willing to receive
bevacizumab vs eligible and not willing to receive bevacizumab). Patients are randomized to
1 of 2 treatment arms.
ARM I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with
or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral
placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the
absence of disease progression or unacceptable toxicity. After completion of 6 courses,
patients with stable or responding disease may continue to receive placebo (with or without
bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm
I. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment
repeats every 21 days for 6 courses in the absence of disease progression or unacceptable
toxicity. After completion of 6 courses, patients with stable or responding disease may
continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the
absence of disease progression or unacceptable toxicity.
Blood and tissue samples are collected for correlative laboratory studies.
After completion of study treatment, patients are followed up periodically for 5 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Progression-free survival (PFS)
From randomization to progression of disease or death, whichever occurs first, up to 5 years
No
Corey Langer
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2011-01967
NCT00976677
January 2010
Name | Location |
---|---|
Hurley Medical Center | Flint, Michigan 48503 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Parkland Memorial Hospital | Dallas, Texas 75235 |
Memorial Hospital | Carthage, Illinois 62321 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Proctor Hospital | Peoria, Illinois 61614 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Mercy Medical Center | Springfield, Ohio 45504 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Eureka Hospital | Eureka, Illinois 61530 |
Graham Hospital Association | Canton, Illinois 61520 |
Saint Joseph Medical Center | Joliet, Illinois 60435 |
Trinity Medical Center | Moline, Illinois 61265-1291 |
Pekin Hospital | Pekin, Illinois 61554 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Longmont United Hospital | Longmont, Colorado 80501 |
Zale Lipshy University Hospital | Dallas, Texas 75235-7786 |
Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Presbyterian - Saint Lukes Medical Center - Health One | Denver, Colorado 80218 |
University of Texas Southwestern Medical Center | Dallas, Texas |
Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
OSF Saint Francis Medical Center | Peoria, Illinois 61637 |
The Medical Center of Aurora | Aurora, Colorado 80012 |
Penrose-Saint Francis Healthcare | Colorado Springs, Colorado 80907 |
Saint Anthony Central Hospital | Denver, Colorado 80204 |
Exempla Saint Joseph Hospital | Denver, Colorado 80218 |
Colorado Cancer Research Program CCOP | Denver, Colorado 80224-2522 |
Saint Mary's Hospital and Regional Medical Center | Grand Junction, Colorado 81502 |
Saint Mary Corwin Medical Center | Pueblo, Colorado 81004 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Stoffel, Thomas J MD (UIA Investigator) | Moline, Illinois 61265 |
Garneau, Stewart C MD (UIA Investigator) | Moline, Illinois 61265 |
Sharis, Christine M MD (UIA Investigator) | Moline, Illinois 61265 |
Porubcin, Michael MD (UIA Investigator) | Moline, Illinois 61265 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
Illinois CancerCare-Ottawa Clinic | Ottawa, Illinois 61350 |
Ottawa Regional Hospital and Healthcare Center | Ottawa, Illinois 61350 |
Pekin Cancer Treatment Center | Pekin, Illinois 61554 |
Illinois Oncology Research Association CCOP | Peoria, Illinois 61615 |
Illinois CancerCare-Peoria | Peoria, Illinois 61615 |
Illinois Valley Hospital | Peru, Illinois 61354 |
McFarland Clinic | Ames, Iowa 50010 |
Constantinou, Costas L MD (UIA Investigator) | Bettendorf, Iowa 52722 |
Cedar Rapids Oncology Association | Cedar Rapids, Iowa 52403 |
Mercy Hospital | Cedar Rapids, Iowa 52403 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Siouxland Hematology - Oncology Associates | Sioux City, Iowa 51101 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Saint Mary's Medical Center | Duluth, Minnesota 55805 |
Miller-Dwan Hospital | Duluth, Minnesota 55805 |
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County | Mount Holly, New Jersey 08060 |
Virtua West Jersey Hospital Voorhees | Voorhees, New Jersey 08043 |
Aultman Health Foundation | Canton, Ohio 44710 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Mainline Health CCOP | Wynnewood, Pennsylvania 19096 |
Dean Hematology and Oncology Clinic | Madison, Wisconsin 53717 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
Illinois CancerCare-Bloomington | Bloomington%, Illinois 61701 |
Illinois CancerCare-Canton | Canton, Illinois 61520 |
Illinois CancerCare-Carthage | Carthage, Illinois 62321 |
Illinois CancerCare-Eureka | Eureka, Illinois 61530 |
Illinois CancerCare-Havana | Havana, Illinois 62644 |
Illinois CancerCare-Kewanee Clinic | Kewanee, Illinois 61443 |
Illinois CancerCare-Macomb | Macomb, Illinois 61455 |
Illinois CancerCare-Monmouth | Monmouth, Illinois 61462 |
Illinois CancerCare-Community Cancer Center | Normal, Illinois 61761 |
Illinois CancerCare-Pekin | Pekin, Illinois 61603 |
Illinois CancerCare-Peru | Peru, Illinois 61354 |
Illinois CancerCare-Princeton | Princeton, Illinois 61356 |
Illinois CancerCare-Spring Valley | Spring Valley, Illinois 61362 |
Saint Paul Hospital | Dallas, Texas 75235 |
Spector, David MD (UIA Investigator) | Moline, Illinois 61265 |
Southwest General Health Center Ireland Cancer Center | Middleburg Heights, Ohio 44130 |
UHHS-Chagrin Highlands Medical Center | Orange Village, Ohio 44122 |
UHHS-Westlake Medical Center | Westlake, Ohio 44145 |
Oncology Associates at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Essentia Health Duluth Clinic CCOP | Duluth, Minnesota 55805 |
Geisinger Medical Center-Cancer Center Hazelton | Hazleton, Pennsylvania 18201 |