Panitumumab, Chemotherapy, and External-Beam Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot be Removed by Surgery
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed unresectable adenocarcinoma of the pancreas
Including subtotal resection and gross residual disease
- No microscopic residual disease only
- Measurable disease is not required
- Disease is encompassable within standard radiotherapy fields for pancreatic cancer
- No evidence of metastatic disease outside of the planned radiotherapy field
- No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin
- No distant metastases (i.e., liver or lung metastases or peritoneal spread)
- No history or known presence of CNS metastases
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- ANC ≥ 1,500/mm³
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ 3 times upper limit of normal (ULN)* NOTE: *Biliary stent placement or surgical bypass should be considered prior to treatment if impending bile duct obstruction by tumor
- AST ≤ 3 times ULN
- Creatinine ≤ 2.0 times ULN
- Magnesium normal
- Willing to return to an North Central Cancer Treatment Group (NCCTG) institution for follow-up
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 6 months after treatment with panitumumab
- No prior or concurrent malignancy unless disease-free ≥ 3 years except for non-melanoma skin cancer, carcinoma in situ of the cervix, or organ confined prostate cancer with Gleason score < 7
- No nausea or vomiting > grade 1
No uncontrolled intercurrent illness including, but not limited to, any the following:
- Ongoing or active infection
- Psychiatric illness or social situations that would limit compliance with study requirements
No New York Heart Association clinically significant cardiovascular disease ≥ grade 2, including any of the following within the past year:
- Myocardial infarction
- Unstable angina
- Symptomatic congestive heart failure
- Serious, uncontrolled cardiac arrhythmia
- No known HIV positivity
- No known hepatitis C virus or acute or chronic active hepatitis B infection
- Adequate oral nutrition
PRIOR CONCURRENT THERAPY:
- More than 21 days since prior laparotomy
- No prior anti-epidermal growth factor receptor (EGFR) antibody therapy (e.g., cetuximab)
- No prior small molecule EGFR inhibitors (e.g., gefitinib, erlotinib, or lapatinib)
- No prior radiotherapy that would overlap with planned radiotherapy fields
- No prior or other concurrent chemotherapy
- No prior or other concurrent biologic therapy
- More than 4 weeks since prior and no concurrent or planned participation in another experimental drug study except studies with specific interventions intended to treat rashes associated with EGFR agents (e.g., N05C4)
- No concurrent enteral hyperalimentation
- No concurrent chronic immunosuppressive agents (e.g., methotrexate, cyclosporine, or corticosteroids)
- No concurrent colony-stimulating factors during the first course of therapy
- No other concurrent immunotherapy or radiotherapy
Sites / Locations
- Aurora Presbyterian Hospital
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- St. Anthony Central Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- CCOP - Colorado Cancer Research Program
- Swedish Medical Center
- Front Range Cancer Specialists
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
- North Colorado Medical Center
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- McKee Medical Center
- St. Mary - Corwin Regional Medical Center
- North Suburban Medical Center
- Exempla Lutheran Medical Center
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Mayo Clinic - Jacksonville
- Illinois CancerCare - Bloomington
- St. Joseph Medical Center
- Graham Hospital
- Illinois CancerCare - Canton
- Illinois CancerCare - Carthage
- Memorial Hospital
- Eureka Community Hospital
- Illinois CancerCare - Eureka
- Galesburg Clinic, PC
- Galesburg Cottage Hospital
- Illinois CancerCare - Galesburg
- InterCommunity Cancer Center of Western Illinois
- Illinois CancerCare - Havana
- Mason District Hospital
- Illinois CancerCare - Kewanee Clinic
- Illinois CancerCare - Macomb
- McDonough District Hospital
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
- Illinois CancerCare - Monmouth
- OSF Holy Family Medical Center
- BroMenn Regional Medical Center
- Community Cancer Center
- Illinois CancerCare - Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Illinois CancerCare - Pekin
- Proctor Hospital
- OSF St. Francis Medical Center
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- Illinois CancerCare - Peru
- Illinois Valley Community Hospital
- Illinois CancerCare - Princeton
- Perry Memorial Hospital
- Illinois CancerCare - Spring Valley
- Valley Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Elkhart Clinic, LLC
- Elkhart General Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Reid Hospital & Health Care Services
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Michiana Hematology-Oncology, PC - South Bend
- Saint Joseph Regional Medical Center
- South Bend Clinic
- McFarland Clinic, PC
- Cedar Rapids Oncology Associates
- Mercy Regional Cancer Center at Mercy Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- McCreery Cancer Center at Ottumwa Regional
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Hospital District Sixth of Harper County
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Southwest Medical Center
- Cancer Center of Kansas, PA - Liberal
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Wesley Medical Center
- Cancer Center of Kansas, PA - Winfield
- Hickman Cancer Center at Bixby Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Battle Creek Health System Cancer Care Center
- Mecosta County Medical Center
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Green Bay Oncology, Limited - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Butterworth Hospital at Spectrum Health
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Dickinson County Healthcare System
- Foote Memorial Hospital
- Haematology-Oncology Associates of Ohio and Michigan, PC
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital - Monroe
- Mercy General Health Partners
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- Lakeside Cancer Specialists, PLLC
- Lakeland Regional Cancer Care Center - St. Joseph
- Munson Medical Center
- St. John Macomb Hospital
- Metro Health Hospital
- MeritCare Bemidji
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Duluth Clinic Cancer Center - Duluth
- CCOP - Duluth
- Miller - Dwan Medical Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Regions Hospital Cancer Care Center
- Ridgeview Medical Center
- Minnesota Oncology Hematology, PA - Woodbury
- Missouri Baptist Cancer Center
- Arch Medical Services, Incorporated at Center for Cancer Care and Research
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare Cancer Care Services
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Big Sky Oncology
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- Northern Montana Hospital
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Rutherford Hospital
- Bismarck Cancer Center
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- CCOP - MeritCare Hospital
- MeritCare Broadway
- Mary Rutan Hospital
- Wood County Oncology Center
- Adena Regional Medical Center
- North Coast Cancer Care - Clyde
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Medical Center Cancer Care
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Grady Memorial Hospital
- Community Cancer Center
- Hematology Oncology Center
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Wayne Hospital
- Charles F. Kettering Memorial Hospital
- Fairfield Medical Center
- Lima Memorial Hospital
- Strecker Cancer Center at Marietta Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Fisher-Titus Medical Center
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- North Coast Cancer Care, Incorporated
- Mercy Medical Center
- Community Hospital of Springfield and Clark County
- Flower Hospital Cancer Center
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- St. Anne Mercy Hospital
- Toledo Clinic, Incorporated - Main Clinic
- UVMC Cancer Care Center at Upper Valley Medical Center
- Fulton County Health Center
- Mount Carmel St. Ann's Cancer Center
- Clinton Memorial Hospital
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Genesis - Good Samaritan Hospital
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Providence Milwaukie Hospital
- Providence Cancer Center at Providence Portland Medical Center
- Adventist Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- Geisinger Cancer Institute at Geisinger Health
- Geisinger Hazleton Cancer Center
- Geisinger Medical Group - Scenery Park
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- AnMed Cancer Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Rapid City Regional Hospital
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Fredericksburg Oncology, Incorporated
- Southwest Washington Medical Center Cancer Center
- Marshfield Clinic - Chippewa Center
- Center for Cancer Treatment & Prevention at Sacred Heart Hospital
- Marshfield Clinic Cancer Care at Regional Cancer Center
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Holy Family Memorial Medical Center Cancer Care Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Marshfield Clinic - Marshfield Center
- Saint Joseph's Hospital
- Marshfield Clinic - Lakeland Center
- Green Bay Oncology, Limited - Oconto Falls
- Ministry Medical Group at Saint Mary's Hospital
- Marshfield Clinic - Indianhead Center
- Marshfield Clinic at Saint Michael's Hospital
- Saint Michael's Hospital Cancer Center
- Door County Cancer Center at Door County Memorial Hospital
- Green Bay Oncology, Limited - Sturgeon Bay
- Marshfield Clinic - Wausau Center
- Diagnostic and Treatment Center
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
Panitumumab
Chemotherapy concurrent with radiation: Radiation 5 days per week for 5½ weeks; Panitumumab on days 1, 15, and 29 of radiation therapy 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation. 4-6 weeks after completion of radiation therapy: Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; Panitumumab on days 1 and 15 of each cycle, for 3 cycles. Maintenance therapy: Panitumumab on days 1 and 15 of each cycle, for 6 cycles.