A Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/Paclitaxel/OSI-774 (Erlotinib; NSC-718781) or OSI-774 Alone in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Performance Status 2 (PS-2)
OBJECTIVES:
Primary
- To select a regimen (erlotinib hydrochloride with or without carboplatin and
paclitaxel) for further testing against standard treatment, based on median
progression-free survival for ≥ 3 months, in patients with stage IIIB or IV non-small
cell lung cancer with a Zubrod performance status of 2.
Secondary
- To assess the feasibility of selecting patients for a trial based on central EGFR
testing of serum in a cooperative group setting.
- To evaluate the objective tumor response rates (confirmed and unconfirmed, complete and
partial response), in a subset of patients with measurable disease.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes
on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats
every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses,
patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with
erlotinib hydrochloride repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 2 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Selection of one of two treatment regimens (erlotinib hydrochloride with or without carboplatin and paclitaxel) for further study in a phase III trial, based on median progression-free survival for ≥ 3 months
From date of registration to 3 years or death, whichever comes first
No
Primo N. Lara, MD
Study Chair
University of California, Davis
United States: Federal Government
CDR0000593575
NCT00661193
December 2008
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Harrington Cancer Center | Amarillo, Texas 79106 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
Kaiser Permanente Medical Center - Vallejo | Vallejo, California 94589 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Kaiser Permanente Medical Center - San Francisco Geary Campus | San Francisco, California 94115 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Kaiser Permanente Medical Center - Oakland | Sacramento, California 95825 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Lahey Clinic Medical Center - Burlington | Burlington, Massachusetts 01805 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington 98273 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
North Puget Oncology at United General Hospital | Sedro-Wooley, Washington 98284 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Kaiser Permanente Medical Center - Santa Clara Kiely Campus | Santa Clara, California 95051-5386 |
Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise, Idaho 83712-6297 |
Kaiser Permanente Medical Center - Sacramento | Sacramento, California 95825 |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Peninsula Medical Center | Burlingame, California 94010 |
Kaiser Permanente - Fremont | Fremont, California 94538 |
Sutter Health - Western Division Cancer Research Group | Greenbrae, California 94904 |
Kaiser Permanente Medical Center - Hayward | Hayward, California 94545 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Kaiser Permanente Medical Center - Redwood City | Redwood City, California 94063 |
Kaiser Permanente Medical Center - Richmond | Richmond, California 94801 |
Kaiser Permanente Medical Center - Roseville | Roseville, California 95661 |
South Sacramento Kaiser-Permanente Medical Center | Sacramento, California 95823 |
California Pacific Medical Center - California Campus | San Francisco, California 94118 |
Kaiser Permanente Medical Center - Santa Teresa | San Jose, California 95119 |
Kaiser Foundation Hospital - San Rafael | San Rafael, California 94903 |
Kaiser Permanente Medical Center - Santa Rosa | Santa Rosa, California 95403 |
Kaiser Permanente Medical Center - South San Francisco | South San Francisco, California 94080 |
Kaiser Permanente Medical Facility - Stockton | Stockton, California 95210 |
Sutter Solano Medical Center | Vallejo, California 94589 |
Kaiser Permanente Medical Center - Walnut Creek | Walnut Creek, California 94596 |
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
St. Francis Comprehensive Cancer Center | Topeka, Kansas 66606 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Minor and James Medical, PLLC | Seattle, Washington 98104 |
Polyclinic First Hill | Seattle, Washington 98122 |
Highland General Hospital | Oakland, California 94602 |
Pearlman Comprehensive Cancer Center at South Georgia Medical Center | Valdosta, Georgia 31603 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Randolph Hospital | Asheboro, North Carolina 27203 |
Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro, North Carolina 27401 |
Kaiser Permanente - Deer Valley | Antioch, California 94531 |
Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
Kaiser Permanente - Moanalua Medical Center and Clinic | Honolulu, Hawaii 96819 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Truman Medical Center - Hospital Hill | Kansas City, Missouri 64108 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Columbia Basin Hematology | Kennewick, Washington 99336 |
Harrison Poulsbo Hematology and Onocology | Poulsbo, Washington 98370 |
Evergreen Hematology and Oncology, PS | Spokane, Washington 99218 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Doctors Medical Center - San Pablo Campus | San Pablo, California 94806 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
Tibotec Therapeutics - Division of Ortho Biotech Products, LP | Marysville, California 95901 |
El Camino Hospital Cancer Center | Mountain View, California 94040 |
Tahoe Forest Cancer Center | Truckee, California 96161 |
Mount Carmel Regional Cancer Center | Pittsburg, Kansas 66762 |
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville, Virginia 24115 |
Kansas City Cancer Centers - Southwest | Overland Park, Kansas 66210 |
Hays Medical Center | Hays, Kansas 67601 |
Hutchinson Hospital Corporation | Hutchinson, Kansas 67502 |
Island Hospital Cancer Care Center at Island Hospital | Anacortes, Washington 98221 |
Highline Medical Center Cancer Center | Burien, Washington 98166 |
Saint Luke's Mountain States Tumor Institute | Boise, Idaho 83712 |
Kansas City Cancer Centers - North | Kansas City, Missouri 64154 |
Kansas City Cancer Centers - South | Kansas City, Missouri 64131 |
Saint Luke's Mountain States Tumor Institute - Fruitland | Fruitland, Idaho 83619 |
Mountain States Tumor Institute - Meridian | Meridian, Idaho 83642 |
Mountain States Tumor Institute at St. Luke's | Twin Falls, Idaho 83301 |
St. Rose Ambulatory and Surgery Center | Great Bend, Kansas 67530 |
Kansas City Cancer Centers - West | Kansas City, Kansas 66112 |
Kansas City Cancer Center - Shawnee Mission | Shawnee Mission, Kansas 66204 |
Kansas City Cancer Centers - East | Lee's Summit, Missouri 64064 |
Kaiser Permanente Medical Center - Vacaville | Vacaville, California 95688 |
Swedish Medical Center - Issaquah Campus | Issaquah, Washington 98029 |
Epic Care - Oakland | Oakland, California 94612 |
Veterans Affairs Medical Center - Topeka (O'Neil) | Topeka, Kansas 66622 |