A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (RHUMAB VEGF; NSC 704865) in Never-Smokers With Stage IIIB and IV Primary NSCLC Adenocarcinomas
OBJECTIVES:
Primary
- Assess overall survival of patients with stage IIIB or IV primary non-small cell lung
adenocarcinoma who have never smoked and are treated with erlotinib hydrochloride and
bevacizumab.
Secondary
- Assess progression-free survival of patients treated with this regimen.
- Assess the response rate (confirmed and unconfirmed, complete and partial) in a subset
of patients with measurable disease treated with this regimen.
- Evaluate the frequency and severity of toxicities associated with this regimen in these
patients.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride daily on days 1-21 and bevacizumab IV over
30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
From time of registration to maximum of 3 years
No
Howard L. West, MD
Study Chair
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
United States: Food and Drug Administration
CDR0000531056
NCT00445848
July 2007
July 2013
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
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 - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
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 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Northside Hospital Cancer Center | Atlanta, Georgia 30342-1611 |
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 |
Broward General Medical Center Cancer Center | Ft. Lauderdale, Florida 33316 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Interlakes Oncology/Hematology PC | Rochester, New York 14623 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
Munson Medical Center | Traverse City, Michigan 49684 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
Big Sky Oncology | Great Falls, Montana 59405 |
St. Peter's Hospital | Helena, Montana 59601 |
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 |
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 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Kaiser Permanente Medical Center - Santa Clara Kiely Campus | Santa Clara, California 95051-5386 |
Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
Kaiser Permanente Medical Center - Sacramento | Sacramento, California 95825 |
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 |
Marin Cancer Institute at Marin General Hospital | Greenbrae, California 94904 |
Kaiser Permanente Medical Center - Hayward | Hayward, California 94545 |
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 |
Kaiser Permanente Medical Center - Walnut Creek | Walnut Creek, California 94596 |
Saint Joseph's Hospital of Atlanta | Atlanta, Georgia 30342-1701 |
Piedmont Hospital | Atlanta, Georgia 30309 |
WellStar Cobb Hospital | Austell, Georgia 30106 |
Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur, Georgia 30033 |
Gwinnett Medical Center | Lawrenceville, Georgia 30045 |
Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta, Georgia 30060 |
Southern Regional Medical Center | Riverdale, Georgia 30274-2600 |
Edward Hospital Cancer Center | Naperville, Illinois 60540 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Highland Hospital of Rochester | Rochester, New York 14620 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Minor and James Medical, PLLC | Seattle, Washington 98104 |
Polyclinic First Hill | Seattle, Washington 98122 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Montrose Memorial Hospital Cancer Center | Montrose, Colorado 81401 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
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 |
Annie Penn Cancer Center | Reidsville, North Carolina 27320 |
Kaiser Permanente - Deer Valley | Antioch, California 94531 |
Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
Kaiser Permanente - Denver | Denver, Colorado 80205 |
Kaiser Permanente - Lafayette | Lafayette, Colorado 80026 |
John B. Amos Cancer Center | Columbus, Georgia 31904 |
Harbin Clinic Cancer Center - Medical Oncology | Rome, Georgia 30165 |
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah, Georgia 31405 |
Kaiser Permanente - Moanalua Medical Center and Clinic | Honolulu, Hawaii 96819 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Liberal | Liberal, Kansas 67905 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cotton-O'Neil Cancer Center | Topeka, Kansas 66606 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
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 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Northern Montana Hospital | Havre, Montana 59501 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
Adventist Medical Center | Portland, Oregon 97216 |
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 |
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Great Falls, Montana 59405 | |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Boston University Cancer Research Center | Boston, Massachusetts 02118 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Tibotec Therapeutics - Division of Ortho Biotech Products, LP | Marysville, California 95901 |
Valley Medical Oncology Consultants - Pleasanton | Pleasanton, California 94588 |
Tahoe Forest Cancer Center | Truckee, California 96161 |
Mercy General Health Partners | Muskegon, Michigan 49443 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
Shaw Regional Cancer Center | Edwards, Colorado 81632 |
Valley View Hospital Cancer Center | Glenwood Springs, Colorado 81601 |
Central Dupage Cancer Center | Warrenville, Illinois 60555 |
Cancer Care Center of Decatur | Decatur, Illinois 62526 |