A Phase II Randomized Study of OSI-774 (Erlotinib) (NSC #718781; IND# 63,383) With or Without Carboplatin/Paclitaxel in Patients With Previously Untreated Adenocarcinoma of the Lung Who Never Smoked or Were Former Light Smokers
PRIMARY OBJECTIVES:
I. Determine the progression-free survival of patients with chemotherapy-naïve select stage
IIIB or stage IV non-small cell lung cancer treated with erlotinib with or without
carboplatin and paclitaxel.
SECONDARY OBJECTIVES:
I. Determine the radiographic response rate in patients treated with these regimens.
II. Correlate the frequency of epidermal growth factor receptor (EGFR) mutations and K-ras
mutations with the response rate and time to progression in patients treated with these
regimens.
III. Determine the median and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.
ARM I: Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days
in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3
hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up
to 6 courses in the absence of disease progression or unacceptable toxicity. After
completion of 6 courses of treatment, patients may continue to receive erlotinib alone as
above.
After completion of study treatment, patients are followed at least every 3 months for 1
year and then every 6 months for up to 2 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS) rate
The product limit estimator developed by Kaplan and Meier will be used to graphically describe progression free survival for patients randomized to each study arm.
At 18 weeks
No
Pasi Janne
Principal Investigator
Cancer and Leukemia Group B
United States: Food and Drug Administration
NCI-2009-00464
NCT00126581
August 2005
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
North Shore University Hospital | Manhasset, New York 11030 |
Franklin Square Hospital Center | Baltimore, Maryland 21237 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Saint Rose Hospital | Hayward, California 94545 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Great Plains Regional Medical Center | North Platte, Nebraska 69101-6598 |
Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
Wilson Medical Center | Wilson, North Carolina 27893-3428 |
Mountainview Medical | Berlin, Vermont 05602 |
Highland General Hospital | Oakland, California 94602 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Center for Cancer Care and Research | St. Louis, Missouri 63141 |
Memorial Hospital of Rhode Island | Pawtucket, Rhode Island 02860 |
Lowell General Hospital | Lowell, Massachusetts 01854 |
Miriam Hospital | Providence, Rhode Island 02906 |
Washington Hospital Center | Washington, District of Columbia 20010 |
Saint Francis Medical Center | Grand Island, Nebraska 68802 |
McLeod Regional Medical Center | Florence, South Carolina 29501 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
Duke University Medical Center | Durham, North Carolina 27710 |
Rappahannock General Hospital | Kilmarnock, Virginia 22482 |
Cancer Care Associates | Tulsa, Oklahoma 74136 |
East Bay Radiation Oncology Center | Castro Valley, California 94546 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
Larry G Strieff MD Medical Corporation | Oakland, California 94609 |
Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
El Camino Hospital | Mountain View, California 94040 |
University of California at San Diego | La Jolla, California 92093 |
South Shore Hospital | South Weymouth, Massachusetts 02190 |
University Of Vermont | Burlington,, Vermont 05403 |
Kaiser Permanente | Sacramento, California |
Ralph Lauren Center for Cancer Care and Prevention | New York, New York 10035 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Valley Medical Oncology Consultants-Castro Valley | Castro Valley, California 94546 |
Eden Hospital Medical Center | Castro Valley, California 94546 |
Valley Medical Oncology Consultants-Fremont | Fremont, California 94538 |
Bay Area Breast Surgeons Inc | Oakland, California 94609 |
Bay Area Tumor Institution CCOP | Oakland, California 94609 |
Tom K Lee Inc | Oakland, California 94609 |
Valley Medical Oncology Consultants | Pleasanton, California 94588 |
Valley Care Health System - Pleasanton | Pleasanton, California 94588 |
University of California San Diego - Veterans Administration | San Diego, California 92161 |
University of California San Francisco Medical Center-Mount Zion | San Francisco, California 94115 |
Doctors Medical Center- JC Robinson Regional Cancer Center | San Pablo, California 94806 |
Middlesex Hospital | Middletown, Connecticut 06457 |
Lombardi Comprehensive Cancer Center at Georgetown University | Washington, District of Columbia 20057 |
Saint Joseph's Medical Center | South Bend, Indiana 46617 |
North Shore Medical Center Cancer Center | Peabody, Massachusetts 01960 |
Lakeland Hospital | St. Joseph, Michigan 49085 |
Missouri Baptist Medical Center | Saint Louis, Missouri 63131 |
State University of New York Upstate Medical University | Syracuse, New York 13210 |
Margaret R Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Kinston Medical Specialists PA | Kinston, North Carolina 28501 |
Greenville Memorial Hospital | Greenville, South Carolina 29605 |
University of Maryland Greenebaum Cancer Center | Baltimore, Maryland 21201 |
Jupiter Medical Center | Jupiter, Florida 33458 |
Mount Sinai Medical Center CCOP | Miami Beach, Florida 33140 |
University of Missouri - Ellis Fischel | Columbia, Missouri 65203 |
Veterans Administration | Columbia, Missouri 65201 |
University of Minnesota Medical Center-Fairview | Minneapolis, Minnesota 55455 |
Capital Regional Medical Center | Jefferson City, Missouri 65101 |
Saint Joseph's Hospital Health Center | Syracuse, New York 13203 |
Saint Joseph Hospital | Nashua, New Hampshire 03060 |
Cancer and Leukemia Group B | Chicago, Illinois 60606 |
North Shore-LIJ Health System CCOP | Manhasset, New York 11030 |
Community Howard Regional Health | Kokomo, Indiana 46904 |
Indiana University Health La Porte Hospital | La Porte, Indiana 46350 |