S0819: Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer
Recurrent Large Cell Lung Carcinoma, Recurrent Lung Adenocarcinoma, Recurrent Squamous Cell Lung Carcinoma

About this trial
This is an interventional treatment trial for Recurrent Large Cell Lung Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients must have histologically or cytologically proven primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous or unspecified); disease must be stage IV; disease may be either newly diagnosed or recurrent after previous surgery and/or irradiation; patients with additional lesions in an ipsilateral non-primary lobe without M1a or M1b disease will not be considered to have stage IV disease and are not eligible
- Patients must have a computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to registration; patient must not have brain metastases unless: (1) metastases have been treated and have remained controlled for at least two weeks following treatment, AND (2) patient has no residual neurological dysfunction off corticosteroids for at least 1 day
- Patients may have measurable or non-measurable disease documented by CT or MRI; the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality; measurable disease must be assessed within 28 days prior to registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form
- Patients must have tumor tissue available for submission that is sufficient for EGFR FISH testing and must agree to submission of these specimens; patients must also agree to submission of specimens for other translational medicine studies; patient must be offered participation in banking for future research
- Patients must not have received prior chemotherapy for any stage non-small cell lung cancer; patients must not have received prior platinum-based chemotherapy for any purpose; patient must not have received any cetuximab, gefitinib, erlotinib, or other investigational agents that target the EGFR pathway; patients must not have received for any purpose prior bevacizumab or other vascular endothelial growth factor (VEGF)-related agents; patients must not have received for any purpose prior chimerized or murine monoclonal antibody therapy or have documented presence of human anti-mouse antibodies (HAMA)
- Prior radiation is permitted; however, patients must have recovered from all associated toxicities at time of registration; in order to qualify as measurable, measurable disease must be outside the previous radiation field or must have progressed
Time from surgical or biopsy procedures is dependent on whether it is planned for the patient to receive bevacizumab
- For patients who are bevacizumab-appropriate AND bevacizumab is planned: at least 28 days must have elapsed since major surgery (i.e. thoracotomy or video-assisted thoracoscopic surgery [VATS] resection of lung cancer, open pleural biopsy or another major surgical procedure such as abdominal surgery) or significant traumatic injury; patients must have recovered from all associated toxicities at the time of registration; there must be no anticipation of need for major surgical procedures during protocol treatment; patients must not have had a core biopsy, mediastinoscopy, pleurodesis, VATS pleural biopsy or VATS pericardial window within 14 days prior to registration; patients must not have had a percutaneous fine needle aspiration (FNA), thoracentesis or central venous access device implanted within 7 days prior to registration; for other surgical procedures not listed here, please contact the study coordinators
- For patients who are bevacizumab-inappropriate or bevacizumab is not planned: at least 28 days must have elapsed since major surgery (i.e. thoracotomy or VATS resection of lung cancer, open pleural biopsy or another major surgical procedure such as abdominal surgery) or significant traumatic injury; patients must have recovered from all associated toxicities at the time of registration; there must be no anticipation of need for major surgical procedures during protocol treatment; patients must not have had a core biopsy, mediastinoscopy, pleurodesis, VATS pleural biopsy or VATS pericardial window within 7 days prior to registration; patients must not have had a percutaneous fine needle aspiration (FNA), or thoracentesis within 1 day prior to registration; patients may have had a central venous access device placed at any time prior to registration; for other surgical procedures not listed here, please contact the study coordinators
- Absolute neutrophil count (ANC) >= 1,500/mcl
- Platelet count >= 100,000/mcl
- Hemoglobin >= 9 g/dL
- Serum creatinine =< institutional upper limit of normal (IULN) AND calculated or measured creatinine clearance >= 50 cc/min using the following Cockroft-Gault formula
- For patients who will be receiving bevacizumab, urine protein must be screened by urine analysis for urine protein creatinine (UPC) ratio; for UPC ratio > 0.5, 24-hour urine protein must be obtained and the level must be < 1,000 mg for patient enrollment; the urine protein used to calculate the UPC ratio must be obtained within 14 days prior to registration; UPC or 24-hour protein is not required for patients who will not receive bevacizumab Note: UPC ratio of spot urine is an estimation of the 24-hour urine protein excretion - a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm
- Serum bilirubin =< 2 times IULN (for patients with liver metastases, bilirubin must be =< 5 X IULN)
- Serum glutamic oxaloacetic transaminase (SGOT) OR serum glutamate pyruvate transaminase (SGPT) =< 2 times IULN (for patients with liver metastases, either SGOT or SGPT must be =< 5 X IULN)
- Zubrod performance status 0-1
- Patients must not have >= grade 2 symptomatic neuropathy-sensory (National Cancer Institute [NCI] Common Terminology Criteria version 3.0)
- Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection
- Patients must not have the following: history (within past 6 months) of cerebrovascular accident (CVA), myocardial infarction or unstable angina; or at the time of registration, uncontrolled hypertension, New York Heart Association grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or clinically significant peripheral vascular disease
- Patients must have no known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies (examples include trastuzumab [Herceptin] and epoetin alpha)
- Patients must be willing to provide prior smoking history
No other prior malignancy is allowed except for any of the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I or II cancer from which the patient is currently in complete remission
- Any other cancer from which the patient has been disease-free for 5 years
- Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
- Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Sites / Locations
- Northeast Alabama Regional Medical Center
- Gulf Coast MBCCOP
- Providence Hospital
- Alaska Breast Care and Surgery LLC
- Alaska Regional Hospital
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Fairbanks Memorial Hospital
- The University of Arizona Cancer Center-Orange Grove Campus
- The University of Arizona Cancer Center-North Campus
- The University of Arizona Medical Center-University Campus
- Fowler Family Center for Cancer Care
- University of Arkansas for Medical Sciences
- East Bay Medical Oncology Hematology Medical Associates-Antioch
- Alta Bates Summit Medical Center-Herrick Campus
- Mills - Peninsula Hospitals
- East Bay Radiation Oncology Center
- Eden Hospital Medical Center
- Valley Medical Oncology Consultants-Castro Valley
- Enloe Medical Center
- City of Hope Comprehensive Cancer Center
- Epic Care-Dublin
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Northbay Cancer Center
- Valley Medical Oncology Consultants-Fremont
- Marin General Hospital
- UC San Diego Moores Cancer Center
- Loma Linda University Medical Center
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Contra Costa Regional Medical Center
- Fremont - Rideout Cancer Center
- Mather Veteran Affairs Medical Center
- Mercy UC Davis Cancer Center
- Memorial Medical Center
- El Camino Hospital
- Sutter Cancer Research Consortium
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Larry G Strieff MD Medical Corporation
- Tom K Lee Inc
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Keck Medical Center of USC Pasadena
- Diablo Valley Oncology and Hematology Medical Group-Pleasant Hill
- East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant Hill
- Valley Care Health System - Pleasanton
- Valley Medical Oncology Consultants
- Sutter Roseville Medical Center
- Sutter General Hospital
- University of California Davis Comprehensive Cancer Center
- Saint Helena Hospital
- University of California San Diego
- California Pacific Medical Center-Pacific Campus
- East Bay Medical Oncology Hematology Associates Inc
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Sutter Pacific Medical Foundation
- Tahoe Forest Cancer Center
- Sutter Solano Medical Center/Cancer Center
- Presbyterian Intercommunity Hospital
- San Luis Valley Regional Medical Center
- The Medical Center of Aurora
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Memorial Hospital Colorado Springs
- Denver Health Medical Center
- Porter Adventist Hospital
- Exempla Saint Joseph Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- Denver Veterans Administration Medical Center
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Colorado Cancer Research Program CCOP
- Colorado Blood Cancer Institute
- Mercy Medical Center
- The Shaw Regional Cancer Center
- Comprehensive Cancer Care and Research Institute of Colorado LLC
- Swedish Medical Center
- Valley View Hospital Cancer Center
- Mountain Blue Cancer Care Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Littleton Adventist Hospital
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- North Suburban Medical Center
- Exempla Lutheran Medical Center
- Saint Francis Hospital and Medical Center
- Yale University
- Stamford Hospital/Bennett Cancer Center
- Bayhealth Medical Center at Kent General
- Beebe Medical Center
- Christiana Gynecologic Oncology LLC
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Regional Hematology and Oncology PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- Nanticoke Memorial Hospital
- Christiana Care Health System-Wilmington Hospital
- MedStar Georgetown University Hospital
- Boca Raton Regional Hospital
- Florida Hospital Memorial Medical Center
- Broward Health North
- Holy Cross Hospital
- Gainesville Hematology Oncology Associates
- Jupiter Medical Center
- Mount Sinai Medical Center
- 21st Century Oncology-Orange Park
- Sacred Heart Hospital
- Sacred Heart Medical Oncology Group - Davis Highway
- Phoebe Putney Memorial Hospital
- University Cancer and Blood Center LLC
- Piedmont Hospital
- Atlanta Regional CCOP
- Northside Hospital
- Saint Joseph's Hospital of Atlanta
- Georgia Regents University Medical Center
- Well Star Cobb Hospital
- John B Amos Cancer Center
- Dekalb Medical Center
- Piedmont Fayette Hospital
- Gwinnett Medical Center
- Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Harbin Clinic Medical Oncology and Clinical Research
- Memorial University Medical Center
- Pali Momi Medical Center
- Oncare Hawaii Inc-POB II
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- OnCare Hawaii-Liliha
- Oncare Hawaii Inc-Kuakini
- The Cancer Center of Hawaii-Liliha
- Kapiolani Medical Center for Women and Children
- Tripler Army Medical Center
- Castle Medical Center
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Maui Memorial Medical Center
- Pacific Cancer Institute of Maui
- Saint Alphonsus Cancer Care Center-Boise
- Saint Joseph Regional Medical Center
- Idaho Urologic Institute-Meridian
- Kootenai Cancer Center
- Saint Anthony's Health
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Graham Hospital Association
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- Illinois CancerCare-Carthage
- Memorial Hospital
- Centralia Oncology Clinic
- Mount Sinai Hospital Medical Center
- Jesse Brown Veterans Affairs Medical Center
- University of Illinois
- Swedish Covenant Hospital
- Resurrection Healthcare
- Weiss Memorial Hospital
- Cancer Care Center of Decatur
- Central Illinois CCOP
- Decatur Memorial Hospital
- Crossroads Cancer Center
- Advocate Sherman Hospital
- Eureka Hospital
- Illinois CancerCare-Eureka
- Saint Francis Hospital
- Galesburg Cottage Hospital
- Illinois CancerCare Galesburg
- Illinois CancerCare-Galesburg Cottage Plaza Office
- Western Illinois Cancer Treatment Center
- Cadence Cancer Center at Delnor
- Illinois CancerCare-Havana
- Mason District Hospital
- Hines Veterans Administration Hospital
- Joliet Oncology-Hematology Associates Limited
- Presence Saint Mary's Hospital
- Illinois CancerCare-Kewanee Clinic
- Adventist La Grange Memorial Hospital
- Illinois CancerCare-Macomb
- Mcdonough District Hospital
- Loyola University Medical Center
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Spector, David MD (UIA Investigator)
- Trinity Medical Center
- Holy Family Medical Center
- Illinois CancerCare-Monmouth
- Good Samaritan Regional Health Center
- Edward Hospital/Cancer Center
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Illinois CancerCare-Community Cancer Center
- Mid-Illinois Hematology Oncology Associates
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Radiation Oncology of Northern Illinois
- Illinois CancerCare-Pekin
- Pekin Cancer Treatment Center
- Pekin Hospital
- Methodist Medical Center of Illinois
- Proctor Hospital
- OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC
- Illinois CancerCare-Peoria
- Illinois Oncology Research Association CCOP
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois Valley Hospital
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Perry Memorial Hospital
- West Suburban Medical Center
- SwedishAmerican Regional Cancer Center/ACT
- Illinois CancerCare-Spring Valley
- Saint Margaret's Hospital
- Memorial Medical Center
- Cadence Cancer Center in Warrenville
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- IU Health Central Indiana Cancer Centers-East
- Community Howard Regional Health
- IU Health La Porte Hospital
- IU Health Arnett Cancer Care
- Premier Oncology Hematology Associates
- Cancer Care Partners LLC
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- Michiana Hematology Oncology PC-Plymouth
- Reid Hospital and Health Care Services
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium CCOP
- Michiana Hematology Oncology-PC Westville
- Mary Greeley Medical Center
- McFarland Clinic PC-William R Bliss Cancer Center
- Constantinou, Costas L MD (UIA Investigator)
- McFarland Clinic PC-Boone
- Cedar Rapids Oncology Association
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa Oncology Research Association CCOP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- McFarland Clinic PC-Jefferson
- McFarland Clinic PC-Marshalltown
- Mercy Medical Center - North Iowa
- Ottumwa Regional Health Center
- Siouxland Hematology Oncology Associates
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Newman Regional Health
- Cancer Center of Kansas - Fort Scott
- Saint Catherine Hospital
- Saint Rose Ambulatory and Surgery Center
- Hays Medical Center
- Hutchinson Regional Medical Center
- Cancer Center of Kansas-Independence
- Kansas City Cancer Center-West
- Providence Medical Center
- University of Kansas Cancer Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas-Manhattan
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Olathe Cancer Center
- Menorah Medical Center
- Kansas City Cancer Centers-Southwest
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Via Christi Hospital-Pittsburg
- Kansas City CCOP
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Salina Regional Health Center
- Kansas City Cancer Center-Shawnee Mission
- Shawnee Mission Medical Center
- Stormont-Vail Regional Health Center
- Saint Francis Hospital and Medical Center - Topeka
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Main Office
- Via Christi Regional Medical Center
- Wesley Medical Center
- Wichita CCOP
- Cancer Center of Kansas - Winfield
- Oncology Hematology Care Inc-Crestview
- University of Kentucky/Markey Cancer Center
- Baton Rouge General Medical Center
- Hematology/Oncology Clinic LLP
- Mary Bird Perkins Cancer Center
- Ochsner Health Center-Summa
- Ochsner Health Center-Covington
- Robert Veith MD LLC
- Interim LSU Public Hospital
- Louisiana State University Health Science Center
- Tulane University Health Sciences Center
- Ochsner Baptist Medical Center
- Ochsner Medical Center Jefferson
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Mercy Medical Center
- Sinai Hospital of Baltimore
- Franklin Square Hospital Center
- Union Hospital of Cecil County
- Holy Cross Hospital
- Beverly Hospital
- Caritas Saint Elizabeth's Medical Center
- Lahey Hospital and Medical Center
- Addison Gilbert Hospital
- Holy Family Hospital
- Berkshire Hematology Oncology PC
- Bixby Medical Center
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- Michigan Cancer Research Consortium CCOP
- Bronson Battle Creek
- McLaren-Bay Region
- Spectrum Health Big Rapids Hospital
- Great Lakes Cancer Institute
- Oakwood Hospital and Medical Center
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Saint John Hospital and Medical Center
- Green Bay Oncology - Escanaba
- Weisberg Cancer Treatment Center
- Hurley Medical Center
- Genesys Hurley Cancer Institute
- Genesys Regional Medical Center-West Flint Campus
- McLaren Cancer Institute-Flint
- Singh and Arora Hematology Oncology PC
- Genesys Regional Medical Center
- Grand Rapids Clinical Oncology Program
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- McLaren-Greater Lansing
- Sparrow Hospital
- Great Lakes Cancer Institute-Lapeer Campus
- Saint Mary Mercy Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital
- McLaren-Macomb
- McLaren-Central Michigan
- Mercy Health Mercy Campus
- Northern Michigan Regional Hospital
- Saint Joseph Mercy Oakland
- Saint Joseph Mercy Port Huron
- Spectrum Health Reed City Hospital
- Saint Mary's of Michigan
- Lakeland Hospital
- Marie Yeager Cancer Center
- Providence Hospital
- Munson Medical Center
- Saint John Macomb-Oakland Hospital
- Metro Health Hospital
- Sanford Clinic North-Bemidgi
- Fairview Ridges Hospital
- Mercy Hospital
- Fairview-Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Unity Hospital
- Hutchinson Area Health Care
- Mayo Clinic Health Systems-Mankato
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- New Ulm Medical Center
- North Memorial Medical Health Center
- Mayo Clinic
- Metro-Minnesota NCI Community Oncology Research Program
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology and Hematology PA-Woodbury
- Forest General Hospital
- University of Mississippi Medical Center
- Singing River Hospital
- Central Care Cancer Center-Carrie J Babb Cancer Center
- CoxHealth Cancer Center
- Saint Francis Medical Center
- Southeast Cancer Center
- University of Missouri - Ellis Fischel
- Centerpoint Medical Center LLC
- Capital Region Medical Center-Goldschmidt Cancer Center
- Freeman Health System
- Mercy Hospital-Joplin
- Truman Medical Center
- Saint Luke's Cancer Institute
- Saint Luke's Hospital of Kansas City
- Saint Joseph Health Center
- North Kansas City Hospital
- Heartland Hematology and Oncology Associates Incorporated
- Kansas City Veterans Affairs Medical Center
- Kansas City Cancer Center - South
- Research Medical Center
- Kansas City Cancer Centers - North
- Kansas City Cancer Center-Lee's Summit
- Saint Luke's East - Lee's Summit
- Liberty Radiation Oncology Center
- Phelps County Regional Medical Center
- Saint John's Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Joseph Oncology Inc
- Saint Louis Cancer and Breast Institute-South City
- Saint Louis University Hospital
- Missouri Baptist Medical Center
- Christian Hospital Northeast - Northwest
- Center for Cancer Care and Research
- Comprehensive Cancer Care PC
- Saint John's Mercy Medical Center
- Saint Louis-Cape Girardeau CCOP
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Montana Cancer Consortium CCOP
- Northern Rockies Radiation Oncology Center
- Saint Vincent Healthcare
- Frontier Cancer Center and Blood Institute-Billings
- Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Berdeaux, Donald MD (UIA Investigator)
- Big Sky Oncology
- Great Falls Clinic
- Northern Montana Hospital
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Hospital
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Guardian Oncology and Center for Wellness
- CHI Health Saint Francis
- Great Plains Regional Medical Center
- University of Nebraska Medical Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Las Vegas Cancer Center-Henderson
- 21st Century Oncology - Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- University Medical Center of Southern Nevada
- Cancer and Blood Specialists-Shadow
- Nevada Cancer Research Foundation CCOP
- Radiation Oncology Centers of Nevada Central
- 21st Century Oncology - Vegas Sunrise
- Children's Specialty Center of Nevada II
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Radiation Oncology Centers of Nevada Southeast
- Cancer Therapy and Integrative Medicine
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Nevada Cancer Institute-Summerlin Campus
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- 21st Century Oncology - Fort Apache
- Cancer and Blood Specialists-Fort Apache
- Comprehensive Cancer Centers of Nevada
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- 21st Century Oncology - Vegas Tenaya
- Alpine Hematology-Oncology
- Saint Mary's Regional Medical Center
- Radiation Oncology Associates
- Reno Oncology Consultants
- Cooper Hospital University Medical Center
- Veterans Adminstration New Jersey Health Care System
- Hunterdon Medical Center
- Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
- Kennedy Health Systems-Cancer Center
- Robert Wood Johnson University Hospital Somerset
- MD Anderson Cancer Center at Cooper-Voorhees
- Virtua West Jersey Hospital Voorhees
- University of New Mexico
- Coney Island Hospital
- Hematology Oncology Associates of Central New York-East Syracuse
- Arnot Ogden Medical Center
- Glens Falls Hospital
- Winthrop University Hospital
- Columbia University Medical Center
- Nyack Hospital
- Highland Hospital
- Interlakes Foundation Inc-Rochester
- University of Rochester
- Staten Island University Hospital
- State University of New York Upstate Medical University
- Syracuse Veterans Administration Medical Center
- Faxton-Saint Luke's Healthcare
- Cone Health Cancer Center at Alamance Regional
- Carolinas Medical Center
- Carolinas Medical Center - Northeast
- Gaston Memorial Hospital
- Wayne Memorial Hospital
- Park Ridge Hospital Breast Health Center
- Kinston Medical Specialists PA
- Carolinas Medical Center-Union
- Rutherford Hospital
- Cleveland Regional Medical Center
- Iredell Memorial Hospital
- Southeast Cancer Control Consortium CCOP
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Roger Maris Cancer Center
- Sanford Clinic North-Fargo
- Sanford Medical Center-Fargo
- Altru Cancer Center
- Trinity Cancer Care Center
- Akron General Medical Center
- Mary Rutan Hospital
- Strecker Cancer Center-Belpre
- Toledo Clinic Cancer Centers-Bowling Green
- Aultman Health Foundation
- Adena Regional Medical Center
- Oncology Hematology Care Inc-Mercy West
- Oncology and Hematology Care Inc-Taft
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc - Anderson
- Oncology Hematology Care Inc - Kenwood
- Bethesda North Hospital
- Oncology Hematology Care Inc-Blue Ash
- Cleveland Clinic Foundation
- North Coast Cancer Care-Clyde
- Ohio State University Comprehensive Cancer Center
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Columbus CCOP
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Samaritan North Health Center
- Dayton CCOP
- Veteran Affairs Medical Center
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Hematology Oncology Center Incorporated
- Mercy Cancer Center-Elyria
- Oncology Hematology Care Inc-Healthplex
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Wayne Hospital
- Kettering Medical Center
- Fairfield Medical Center
- Lancaster Radiation Oncology
- Saint Rita's Medical Center
- Lima Memorial Hospital
- Marietta Memorial Hospital
- Saint Luke's Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Fisher-Titus Medical Center
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- Southern Ohio Medical Center
- North Coast Cancer Care
- Springfield Regional Medical Center
- Trinity's Tony Teramana Cancer Center
- Flower Hospital
- Mercy Hospital of Tiffin
- The Toledo Hospital/Toledo Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Upper Valley Medical Center
- Fulton County Health Center
- Saint Ann's Hospital
- Clinton Memorial Hospital
- Wright-Patterson Medical Center
- Greene Memorial Hospital
- Genesis HealthCare System
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Oklahoma Oncology Inc
- Natalie Warren Bryant Cancer Center at Saint Francis
- Surgical Associates Inc
- Warren Cancer Research Foundation
- Tulsa Cancer Institute
- Saint Charles Medical Center-Bend
- Clackamas Radiation Oncology Center
- Legacy Mount Hood Medical Center
- Asante Health System
- Providence Milwaukie Hospital
- Providence Newberg Medical Center
- Providence Willamette Falls Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Western Oncology Research Consortium
- Providence Saint Vincent Medical Center
- Compass Oncology Rose Quarter
- Kaiser Permanente
- Legacy Emanuel Hospital and Health Center
- Legacy Meridian Park Hospital
- Butler Memorial Hospital
- Mercy Fitzgerald Hospital
- Easton Hospital
- Ephrata Cancer Center
- Riddle Hospital
- Alle-Kiski Medical Center
- Mercy Suburban Hospital and Cancer Center
- University of Pennsylvania/Abramson Cancer Center
- Thomas Jefferson University Hospital
- Mercy Hospital of Philadelphia
- Phoenixville Hospital
- Allegheny Cancer Center at Allegheny General Hospital
- West Penn Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- Hematology and Oncology Associates of North East Pennsylvania
- Grand View Hospital
- Mount Nittany Medical Center
- Associates In Hematology Oncology PC-Upland
- Jennersville Regional Hospital
- Reading Hospital
- AnMed Health Cancer Center
- AnMed Health Hospital
- Medical University of South Carolina
- Greenville Health System Cancer Institute-Easley
- Saint Francis Hospital
- Greenville Health System Cancer Institute-Andrews
- Greenville Health System Cancer Institute-Butternut
- Greenville Health System Cancer Institute-Faris
- Greenville Memorial Hospital
- Greenville Health System Cancer Institute-Eastside
- Self Regional Healthcare
- Greenville Health System Cancer Institute-Greer
- Gibbs Cancer Center-Pelham
- Carolina Blood and Cancer Care Associates PA-Lancaster
- Carolina Blood and Cancer Care Associates PA
- Greenville Health System Cancer Institute-Seneca
- Spartanburg Medical Center
- Upstate Carolina CCOP
- Greenville Health System Cancer Institute-Spartanburg
- Rapid City Regional Hospital
- Sanford Cancer Center-Oncology Clinic
- Avera Cancer Institute
- Medical X-Ray Center
- Sanford USD Medical Center - Sioux Falls
- Thompson Cancer Survival Center
- University of Tennessee - Knoxville
- Veterans Affairs Medical Center - Memphis
- University of Tennessee Health Science Center
- Meharry Medical College
- Texas Oncology-Austin Midtown
- Texas Oncology - Central Austin Cancer Center
- Texas Oncology - South Austin Cancer Center
- Texas Oncology-Austin North
- Texas Oncology-Cedar Park
- University of Texas Medical Branch at Galveston
- Baylor College of Medicine
- Ben Taub General Hospital
- M D Anderson Cancer Center
- Methodist Hospital
- Saint Luke's Episcopal Hospital
- Veterans Administration Medical Center
- Texas Tech University Health Sciences Center
- Texas Oncology-Seton Williamson
- Texas Oncology - Round Rock Cancer Center
- Audie L Murphy Veterans Affairs Hospital
- Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
- University Hospital
- University of Texas Health Science Center at San Antonio
- Texas Oncology- San Marcos
- Scott and White Memorial Hospital
- Huntsman Cancer Institute/University of Utah
- Southwestern Vermont Medical Center
- Martha Jefferson Hospital
- University of Virginia
- Fredericksburg Oncology Inc
- Cancer Care Center at Island Hospital
- Auburn Regional Medical Center
- Overlake Hospital Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Medical Center-Edmonds
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- Seattle Cancer Care Alliance at EvergreenHealth
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- Skagit Valley Hospital
- Providence - Saint Peter Hospital
- Capital Medical Center
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- MultiCare Good Samaritan Hospital
- Virginia Mason CCOP
- Harborview Medical Center
- Minor and James Medical PLLC
- Pacific Medical Center-First Hill
- Swedish Medical Center-Ballard Campus
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- Group Health Cooperative of Puget Sound Oncology Consortium
- Group Health Cooperative-Seattle
- Swedish Medical Center-First Hill
- The Polyclinic
- University of Washington Medical Center
- United General Hospital
- Cancer Care Northwest - Spokane South
- Evergreen Hematology and Oncology PS
- Rockwood Clinic
- MultiCare Allenmore Hospital
- Northwest CCOP
- Northwest Medical Specialties PLLC
- Saint Joseph Medical Center
- Multicare Health System
- PeaceHealth Southwest Medical Center
- Compass Oncology Vancouver
- Legacy Salmon Creek Hospital
- Providence Saint Mary Regional Cancer Center
- Wenatchee Valley Hospital and Clinics
- Edwards Comprehensive Cancer Center
- Princeton Community Hospital
- Langlade Hospital and Cancer Center
- Fox Valley Hematology and Oncology
- Aurora Cancer Care-Southern Lakes
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Mary's Hospital
- Aurora BayCare Medical Center
- Mercy Health System
- Gundersen Lutheran Medical Center
- Holy Family Memorial Hospital
- Bay Area Medical Center
- Vince Lombardi Cancer Clinic-Marinette
- Cancer Center of Western Wisconsin
- Green Bay Oncology - Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- Wheaton Franciscan Cancer Care - All Saints
- Saint Nicholas Hospital
- Vince Lombardi Cancer Clinic-Sheboygan
- Green Bay Oncology - Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic
- Aspirus Regional Cancer Center
- Riverview Hospital
- Rocky Mountain Oncology
- Welch Cancer Center
- Instituto Nacional De Cancerologia de Mexico
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (chemo +/- bevacizumab)
Arm II (chemo, cetuximab, +/- bevacizumab)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 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, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.
Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.