A Phase II Trial of the Combination of OSI-774 (ERLOTINIB; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma With BAC Features (ADENOBAC)
OBJECTIVES:
Primary
- Determine overall survival of patients with stage IIIB or IV bronchioloalveolar
carcinoma (BAC) or adenocarcinoma with BAC features treated with erlotinib
hydrochloride and bevacizumab.
Secondary
- Determine the progression-free survival of patients treated with this regimen.
- Compare, preliminarily, response as assessed by RECIST criteria vs response as assessed
by a central computer-assisted image-analysis system in patients with measurable
disease treated with this regimen.
- Assess the frequency and severity of toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once 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 every 3 months for 1 year and
then every 6 months for up to 2 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 date 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: Federal Government
CDR0000529756
NCT00436332
July 2007
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
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 - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
LDS Hospital | Salt Lake City, Utah 84143 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Kaiser Permanente Medical Center - Vallejo | Vallejo, California 94589 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Kaiser Permanente Medical Center - San Francisco Geary Campus | San Francisco, California 94115 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Northside Hospital Cancer Center | Atlanta, Georgia 30342-1611 |
Kaiser Permanente Medical Center - Oakland | Sacramento, California 95825 |
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 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
Munson Medical Center | Traverse City, Michigan 49684 |
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 |
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 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
American Fork Hospital | American Fork, Utah 84003 |
Logan Regional Hospital | Logan, Utah 84321 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
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 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
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 |
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 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 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
Minor and James Medical, PLLC | Seattle, Washington 98104 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Kaiser Permanente - Deer Valley | Antioch, California 94531 |
Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
John B. Amos Cancer Center | Columbus, Georgia 31904 |
Harbin Clinic Cancer Center - Medical Oncology | Rome, Georgia 30165 |
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 |
Mary Rutan Hospital | Bellefontaine, Ohio 43311 |
Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
Sandra L. Maxwell Cancer Center | Cedar City, Utah 84720 |
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden, Utah 84403 |
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 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
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 |
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 |
Piedmont Fayette Hospital | Fayetteville, Georgia 30214 |
Kaiser Permanente Medical Center - Vacaville | Vacaville, California 95688 |