S0635: Erlotinib and Bevacizumab in Stage IIIB and IV Bronchioloalveolar Carcinoma
- Conditions
- Lung Cancer
- Interventions
- Biological: bevacizumab
- Registration Number
- NCT00436332
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Erlotinib and Bevacizumab bevacizumab - Erlotinib and Bevacizumab erlotinib hydrochloride -
- Primary Outcome Measures
Name Time Method Overall Survival From date of registration to maximum of 3 years
- Secondary Outcome Measures
Name Time Method Progression-free Survival From date of registration to maximum of 3 years Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease From date of registration to maximum of 3 years Images for response assessed by the central computer-assisted image-analysis system were never collected.
Frequency and Severity of Toxicities From date of registration to maximum of 3 years
Trial Locations
- Locations (148)
Alta Bates Summit Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Kaiser Foundation Hospital - San Rafael
🇺🇸San Rafael, California, United States
Kaiser Permanente Medical Center - Vallejo
🇺🇸Vallejo, California, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Northside Hospital Cancer Center
🇺🇸Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta
🇺🇸Atlanta, Georgia, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Minor and James Medical, PLLC
🇺🇸Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Genesys Regional Medical Center
🇺🇸Grand Blanc, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Mecosta County Medical Center
🇺🇸Big Rapids, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Battle Creek Health System Cancer Care Center
🇺🇸Battle Creek, Michigan, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
St. Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
Mary Rutan Hospital
🇺🇸Bellefontaine, Ohio, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Mount Carmel St. Ann's Cancer Center
🇺🇸Westerville, Ohio, United States
American Fork Hospital
🇺🇸American Fork, Utah, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Logan Regional Hospital
🇺🇸Logan, Utah, United States
Skagit Valley Hospital Cancer Care Center
🇺🇸Mount Vernon, Washington, United States
Grant Medical Center Cancer Care
🇺🇸Columbus, Ohio, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Pardee Memorial Hospital
🇺🇸Hendersonville, North Carolina, United States
Sandra L. Maxwell Cancer Center
🇺🇸Cedar City, Utah, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Knox Community Hospital
🇺🇸Mount Vernon, Ohio, United States
Columbia Basin Hematology
🇺🇸Kennewick, Washington, United States
Harrison Poulsbo Hematology and Onocology
🇺🇸Poulsbo, Washington, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
🇺🇸San Francisco, California, United States
California Pacific Medical Center - California Campus
🇺🇸San Francisco, California, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
Cancer Center of Kansas, PA - Liberal
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas - Fort Scott
🇺🇸Fort Scott, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Tammy Walker Cancer Center at Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Utah Cancer Specialists at UCS Cancer Center
🇺🇸Salt Lake City, Utah, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
🇺🇸Murray, Utah, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
Metro Health Hospital
🇺🇸Wyoming, Michigan, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸Oakland, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
🇺🇸Santa Clara, California, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
🇺🇸Decatur, Georgia, United States
Kaiser Permanente Medical Center - Vacaville
🇺🇸Vacaville, California, United States
Kaiser Permanente - Deer Valley
🇺🇸Antioch, California, United States
Kaiser Permanente Medical Center - Hayward
🇺🇸Hayward, California, United States
Peninsula Medical Center
🇺🇸Burlingame, California, United States
Kaiser Permanente - Fremont
🇺🇸Fremont, California, United States
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
🇺🇸Marysville, California, United States
Kaiser Permanente Medical Center - Redwood City
🇺🇸Redwood City, California, United States
Valley Medical Oncology Consultants - Pleasanton
🇺🇸Pleasanton, California, United States
Kaiser Permanente Medical Center - Richmond
🇺🇸Richmond, California, United States
Kaiser Permanente Medical Center - Roseville
🇺🇸Roseville, California, United States
Sutter Health - Western Division Cancer Research Group
🇺🇸San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Teresa
🇺🇸San Jose, California, United States
Kaiser Permanente Medical Center - Santa Rosa
🇺🇸Santa Rosa, California, United States
Tahoe Forest Cancer Center
🇺🇸Truckee, California, United States
Kaiser Permanente Medical Facility - Stockton
🇺🇸Stockton, California, United States
Kaiser Permanente Medical Center - South San Francisco
🇺🇸South San Francisco, California, United States
Sutter Solano Medical Center
🇺🇸Vallejo, California, United States
Kaiser Permanente Medical Center - Walnut Creek
🇺🇸Walnut Creek, California, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
WellStar Cobb Hospital
🇺🇸Austell, Georgia, United States
John B. Amos Cancer Center
🇺🇸Columbus, Georgia, United States
Piedmont Fayette Hospital
🇺🇸Fayetteville, Georgia, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Gwinnett Medical Center
🇺🇸Lawrenceville, Georgia, United States
Harbin Clinic Cancer Center - Medical Oncology
🇺🇸Rome, Georgia, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
🇺🇸Marietta, Georgia, United States
Southern Regional Medical Center
🇺🇸Riverdale, Georgia, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
Mercy General Health Partners
🇺🇸Muskegon, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Northern Montana Hospital
🇺🇸Havre, Montana, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
Evergreen Hematology and Oncology, PS
🇺🇸Spokane, Washington, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
South Sacramento Kaiser-Permanente Medical Center
🇺🇸Sacramento, California, United States
Kaiser Permanente Medical Center - Sacramento
🇺🇸Sacramento, California, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Kaiser Permanente - Moanalua Medical Center and Clinic
🇺🇸Honolulu, Hawaii, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸Lexington, Kentucky, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cotton-O'Neil Cancer Center
🇺🇸Topeka, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States