Phase II Study of Sorafenib (NSC-724772) and Erlotinib (NSC-718781) in Patients With Advanced Gallbladder Carcinoma or Cholangiocarcinoma
OBJECTIVES:
I. To assess the progression-free survival in patients with unresectable or metastatic
gallbladder carcinoma or cholangiocarcinoma treated with the combination of sorafenib
(sorafenib tosylate) and erlotinib (erlotinib hydrochloride).
II. To assess the overall survival in patients with unresectable or metastatic gallbladder
carcinoma or cholangiocarcinoma treated with the combination of sorafenib and erlotinib.
IV. To assess the frequency and severity of toxicities. V. To collect specimens for banking
for future research.
OUTLINE: This is a multicenter study.
Patients receive sorafenib tosylate orally (PO) twice daily and erlotinib hydrochloride PO
once daily on days 1-28. Treatment repeats every 28 days in the absence of disease
progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 6 months for 3 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years
No
Anthony El-Khoueiry
Principal Investigator
Southwest Oncology Group
United States: Food and Drug Administration
NCI-2011-02027
NCT01093222
April 2010
Name | Location |
---|---|
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Hurley Medical Center | Flint, Michigan 48503 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Sutter Health Western Division Cancer Research Group | Greenbrae, California 94904 |
Loma Linda University Medical Center | Loma Linda, California 92354 |
Boston Medical Center | Boston, Massachusetts 02118 |
William Beaumont Hospital | Royal Oak, Michigan 48073 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Group Health Cooperative | Seattle, Washington 98112 |
Great Falls Clinic | Great Falls, Montana 59405 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Harborview Medical Center | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
Grandview Hospital | Dayton, Ohio 45405 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Menorah Medical Center | Overland Park, Kansas 66209 |
Shawnee Mission Medical Center | Shawnee Mission, Kansas 66204 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Research Medical Center | Kansas City, Missouri 64132 |
Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
Liberty Hospital | Liberty, Missouri 64068 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Mary Rutan Hospital | Bellefontaine, Ohio 43311 |
Wayne Hospital | Greenville, Ohio 45331 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Memorial Medical Center | Springfield, Illinois 62781 |
Wellmont Holston Valley Hospital and Medical Center | Kingsport, Tennessee 37662 |
Queen's Medical Center | Honolulu, Hawaii 96813 |
Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
Maui Memorial Medical Center | Wailuku, Hawaii 96793 |
University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Straub Clinic and Hospital | Honolulu, Hawaii 96813 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Licking Memorial Hospital | Newark, Ohio 43055-2899 |
Columbus CCOP | Columbus, Ohio 43206 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
UC Davis Comprehensive Cancer Center | Sacramento, California 95817 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
University of Southern California | Los Angeles, California 90033 |
Hawaii Medical Center East | Honolulu, Hawaii 96817 |
Fremont - Rideout Cancer Center | Marysville, California 95901 |
Valley Medical Oncology Consultants | Pleasanton, California 94588 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
M D Anderson Cancer Center- Orlando | Orlando, Florida 32806 |
Oncare Hawaii Inc-POB II | Honolulu, Hawaii 96813 |
Oncare Hawaii Inc-Kuakini | Honolulu, Hawaii 96817 |
University of Hawaii | Honolulu, Hawaii 96813 |
Saint Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Saint Luke's Hospital of Kansas City | Kansas City, Missouri 64111 |
Saint Joseph Health Center | Kansas City, Missouri 64114 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Billings Clinic | Billings, Montana 59107-7000 |
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana 59405 |
Berdeaux, Donald MD (UIA Investigator) | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Glacier Oncology PLLC | Kalispell, Montana 59901 |
Community Medical Hospital | Missoula, Montana 59801 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Gaston Memorial Hospital | Gastonia, North Carolina 28054 |
Margaret R Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Doctors Hospital | Columbus, Ohio 43228 |
Grant Medical Center | Columbus, Ohio 43215 |
Mount Carmel Health Center West | Columbus, Ohio 43222 |
Good Samaritan Hospital - Dayton | Dayton, Ohio 45406 |
Dayton CCOP | Dayton, Ohio 45429 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio 45005-1066 |
Kettering Medical Center | Kettering, Ohio 45429 |
Marietta Memorial Hospital | Marietta, Ohio 45750 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Saint Ann's Hospital | Westerville, Ohio 43081 |
Genesis HealthCare System | Zanesville, Ohio 43701 |
AnMed Health Hospital | Anderson, South Carolina 29621 |
Upstate Carolina CCOP | Spartanburg, South Carolina 29303 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Columbia Basin Hematology and Oncology PLLC | Kennewick, Washington 99336 |
Minor and James Medical PLLC | Seattle, Washington 98104 |
The Polyclinic | Seattle, Washington 98122 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
University of California Medical Center At Irvine-Orange Campus | Orange, California 92868 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
Evergreen Hematology and Oncology PS | Spokane, Washington 99218 |
Saint Luke's South Hospital | Overland Park, Kansas 66213 |
Heartland Hematology and Oncology Associates Incorporated | Kansas City, Missouri 64118 |
Southwest Oncology Group | San Antonio, Texas 78245 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
PeaceHealth Saint Joseph Medical Center | Bellingham, Washington 98225 |
Springfield Regional Medical Center | Springfield, Ohio 45505 |
Harrison Poulsbo Hematology and Oncology | Poulsbo, Washington 98370 |