Phase II Study of Panitumumab, Chemotherapy, and External Beam Radiation in Patients With Locally Advanced Pancreatic Cancer
OBJECTIVES:
Primary
- To evaluate the 1-year survival rate in patients with locally advanced pancreatic
cancer treated with panitumumab and continuous infusion fluorouracil administered
concurrently with external-beam radiotherapy followed by gemcitabine and panitumumab.
Secondary
- To determine overall survival, time to disease progression, confirmed response rate,
duration of response, and time to treatment failure in patients treated with this
regimen.
- To determine adverse events in patients treated with this regimen.
OUTLINE:
- Panitumumab and chemoradiotherapy : Patients undergo external-beam radiotherapy once
daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38. Patients also receive
panitumumab IV over 1 hour on days 1, 15, and 29 and fluorouracil IV continuously over
24 hours daily OR oral capecitabine twice daily beginning on day 1 and continuing
through the last day of radiotherapy.
- Panitumumab and chemotherapy: Beginning 4-6 weeks after completion of panitumumab and
chemoradiotherapy, patients receive panitumumab IV over 1 hour on days 1 and 15 and
gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days
for 3 courses. Patients then proceed to maintenance therapy.
- Maintenance therapy: Patients receive panitumumab IV over 1 hour on days 1 and 15.
Treatment repeats every 28 days for 6 courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 1 year.
Interventional
Masking: Open Label, Primary Purpose: Treatment
1-year survival rate
No
George P. Kim, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000584104
NCT00601627
June 2009
Name | Location |
---|---|
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
CCOP - Colorado Cancer Research Program | Denver, Colorado 80224-2522 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
St. Joseph Hospital | Denver, Colorado 80218 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
St. Mary - Corwin Regional Medical Center | Pueblo, Colorado 81004 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
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 |
MeritCare Bemidji | Bemidji, Minnesota 56601 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Duluth Clinic Cancer Center - Duluth | Duluth, Minnesota 55805-1983 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Miller - Dwan Medical Center | Duluth, Minnesota 55805 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
MeritCare Broadway | Fargo, North Dakota 58122 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Geisinger Medical Group - Scenery Park | State College, Pennsylvania 16801 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - Dayton | Kettering, Ohio 45429 |
Hinsdale, Illinois 60521 | |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
Wesley Medical Center | Wichita, Kansas 67214 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
Toledo Hospital | Toledo, Ohio 43606 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
McCreery Cancer Center at Ottumwa Regional | Ottumwa, Iowa 52501 |
Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
Dickinson County Healthcare System | Iron Mountain, Michigan 49801 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Southwest Medical Center | Liberal, Kansas 67901 |
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 |
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 |
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 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
South Bend Clinic | South Bend, Indiana 46617 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
Front Range Cancer Specialists | Fort Collins, Colorado 80528 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
InterCommunity Cancer Center of Western Illinois | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Bettendorf, Iowa 52722 | |
Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Capitol Hospital | Des Moines, Iowa 50307 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
Bismarck Cancer Center | Bismarck, North Dakota 58501 |
Wood County Oncology Center | Bowling Green, Ohio 43402 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Lima Memorial Hospital | Lima, Ohio 45804 |
St. Luke's Hospital | Maumee, Ohio 43537 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
Toledo Clinic - Oregon | Oregon, Ohio 43616 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
North Coast Cancer Care, Incorporated | Sandusky, Ohio 44870 |
Mercy Medical Center | Springfield, Ohio 45504 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
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 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
Holy Family Memorial Medical Center Cancer Care Center | Manitowoc, Wisconsin 54221-1450 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
St. Anthony Central Hospital | Denver, Colorado 80204-1335 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Elkhart Clinic, LLC | Elkhart, Indiana 46514-2098 |
Michiana Hematology-Oncology, PC - South Bend | Mishawaka, Indiana 46545-1470 |
Reid Hospital & Health Care Services | Richmond, Indiana 47374 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Hospital District Sixth of Harper County | Anthony, Kansas 67003 |
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 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
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 |
Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville, Michigan 48144 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Memorial Hospital - Monroe | Monroe, Michigan 48162 |
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 |
Lakeside Cancer Specialists, PLLC | Saint Joseph, Michigan 49085 |
Arch Medical Services, Incorporated at Center for Cancer Care and Research | Saint Louis, Missouri 63141 |
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 |
North Coast Cancer Care - Clyde | Clyde, Ohio 43410 |
Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
Hematology Oncology Center | Elyria, Ohio 44035 |
Community Cancer Center | Elyria, Ohio 44035 |
Wayne Hospital | Greenville, Ohio 45331 |
Fisher-Titus Medical Center | Norwalk, Ohio 44857 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
St. Anne Mercy Hospital | Toledo, Ohio 43623 |
Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
Adventist Medical Center | Portland, Oregon 97216 |
Geisinger Hazleton Cancer Center | Hazleton, Pennsylvania 18201 |
Fredericksburg Oncology, Incorporated | Fredericksburg, Virginia 22401 |
Marshfield Clinic - Chippewa Center | Chippewa Falls, Wisconsin 54729 |
Center for Cancer Treatment & Prevention at Sacred Heart Hospital | Eau Claire, Wisconsin 54701 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
Saint Joseph's Hospital | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Lakeland Center | Minocqua, Wisconsin 54548 |
Ministry Medical Group at Saint Mary's Hospital | Rhinelander, Wisconsin 54501 |
Marshfield Clinic at Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
Saint Michael's Hospital Cancer Center | Stevens Point, Wisconsin 54481 |
Marshfield Clinic - Wausau Center | Wausau, Wisconsin 54401 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Diagnostic and Treatment Center | Weston, Wisconsin 54476 |
Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin 54494 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Great Falls, Montana 59405 | |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Illinois CancerCare - Bloomington | Bloomington%, Illinois 61701 |
Illinois CancerCare - Canton | Canton, Illinois 61520 |
Illinois CancerCare - Carthage | Carthage, Illinois 62321 |
Illinois CancerCare - Eureka | Eureka, Illinois 61530 |
Illinois CancerCare - Galesburg | Galesburg, Illinois 61401 |
Illinois CancerCare - Havana | Havana, Illinois 62644 |
Illinois CancerCare - Kewanee Clinic | Kewanee, Illinois 61443 |
Illinois CancerCare - Macomb | Macomb, Illinois 61455 |
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline, Illinois 61265 |
OSF Holy Family Medical Center | Monmouth, Illinois 61462 |
Illinois CancerCare - Monmouth | Monmouth, Illinois 61462 |
Illinois CancerCare - Community Cancer Center | Normal, Illinois 61761 |
Illinois CancerCare - Pekin | Pekin, Illinois 61603 |
Illinois CancerCare - Peru | Peru, Illinois 61354 |
Illinois CancerCare - Princeton | Princeton, Illinois 61356 |
Illinois CancerCare - Spring Valley | Spring Valley, Illinois 61362 |
Mercy General Health Partners | Muskegon, Michigan 49443 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
Medcenter One Hospital Cancer Care Center | Bismarck, North Dakota 58501 |
St. Alexius Medical Center Cancer Center | Bismarck, North Dakota 58502 |
Door County Cancer Center at Door County Memorial Hospital | Sturgeon Bay, Wisconsin 54235-1495 |