Randomized Phase II Trial of Panitumumab, Erlotinib and Gemcitabine vs. Erlotinib and Gemcitabine in Patients With Untreated, Metastatic Pancreatic Adenocarcinoma
OBJECTIVES:
Primary
- To assess whether the addition of panitumumab (a dual-epidermal growth factor receptor
inhibitor) to standard chemotherapy comprising gemcitabine hydrochloride and erlotinib
hydrochloride results in an improvement in overall survival of patients with previously
untreated, metastatic adenocarcinoma of the pancreas.
Secondary
- To compare objective response rates, progression-free survival, time to treatment
failure, quality of life, and adverse event rates in patients treated with these
regimens.
- To evaluate the downstream marker, KRAS, in stool specimens.
OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance
status (0 vs 1) and prior adjuvant chemotherapy (yes vs no). The first 6 patients are
assigned to arm II. Subsequent patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and
15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28
days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive
2 additional courses of treatment; patients achieving a partial response (PR) receive
retreatment as above in the absence of disease progression or unacceptable toxicity.
Patients achieving a CR after 4 courses of treatment receive maintenance therapy
comprising erlotinib hydrochloride daily until the first disease progression. After the
first progression, patients are retreated with gemcitabine hydrochloride and erlotinib
hydrochloride until second progression (using the first progression tumor measurements
as the new baseline reference).
- Arm II: Patients receive gemcitabine hydrochloride and erlotinib hydrochloride as in
arm I and panitumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days
for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of
treatment; patients achieving a PR receive retreatment as above in the absence of
disease progression or unacceptable toxicity. Patients achieving a CR after 4 courses
of treatment receive maintenance therapy comprising erlotinib hydrochloride daily and
panitumumab every 2 weeks until the first disease progression. After the first
progression, patients are retreated with gemcitabine hydrochloride, erlotinib
hydrochloride, and panitumumab until second progression (using the first progression
tumor measurements as the new baseline reference).
Stool samples are collected at baseline and analyzed for KRAS mutations via protein
analyses.
Quality of life will be assessed at baseline, every 2 courses during treatment, and at the
end of treatment.
After the second progression, patients are followed every 3-6 months for 2 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Overall survival
No
George P. Kim, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000571863
NCT00550836
March 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 - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
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 |
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 |
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 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
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 - Montana Cancer Consortium | Billings, Montana 59101 |
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 - Columbia River Oncology Program | Portland, Oregon 97225 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
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 |
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 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
Alexandria, Minnesota 56308 | |
Coborn Cancer Center | Saint Cloud, Minnesota 56303 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
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 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 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Altru Cancer Center at Altru Hospital | Grand Forks, North Dakota 58201 |
Midelfort Clinic - Luther | Eau Claire, Wisconsin 54702 |
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 |
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 |
Ochsner Health Center - Bluebonnet | Baton Rouge, Louisiana 70809 |
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 |
Fergus Falls Medical Group, PA | Fergus Falls, Minnesota 56537 |
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 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
North Coast Cancer Care - Clyde | Clyde, Ohio 43410 |
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 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
Adventist Medical Center | Portland, Oregon 97216 |
Geisinger Hazleton Cancer Center | Hazleton, Pennsylvania 18201 |
Guthrie Cancer Center at Guthrie Clinic Sayre | Sayre, Pennsylvania 18840 |
Fredericksburg Oncology, Incorporated | Fredericksburg, Virginia 22401 |
Marshfield Clinic - Chippewa Center | Chippewa Falls, Wisconsin 54729 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
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 |
Marshfield Clinic - Wausau Center | Wausau, Wisconsin 54401 |
Marshfield Clinic - Weston 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 |
Queen's Cancer Institute at Queen's Medical Center | Honolulu, Hawaii 96813 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Great Falls, Montana 59405 | |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
Straub Clinic and Hospital, Incorporated | Honolulu, Hawaii 96813 |
Hawaii Medical Center - East | Honolulu, Hawaii 96817 |
OnCare Hawaii, Incorporated - Kuakini | Honolulu, Hawaii 96817 |
OnCare Hawaii, Incorporated - Lusitana | Honolulu, Hawaii 96813 |
Pacific Cancer Institute - Maui | Wailuku, Hawaii 96793 |
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 |
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 |
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 |
Ochsner Health Center - Covington | Covington, Louisiana 70433 |
Luther Midlelfort Hospital | Eau Claire, Wisconsin 54702 |