A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission After Primary Induction Failure
PRIMARY OBJECTIVES:
I. Compare disease-free survival in patients with acute myeloid leukemia in second or
subsequent complete remission or in first complete remission treated with tipifarnib as
maintenance therapy vs observation alone.
SECONDARY OBJECTIVES:
I. Compare overall survival in patients treated with these regimens. II. Determine long-term
safety and toxicity of tipifarnib in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
remission status (first complete remission [CR] vs > first CR) and prior treatment for the
most current remission (consolidation therapy vs no therapy). Patients are randomized to 1
of 2 treatment arms.
ARM I: Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo observation only.
Patients are followed for up to 5 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival
From randomization until relapse or death from any cause, up to 5 years
No
Selina Luger
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2009-00535
NCT00093470
August 2004
Name | Location |
---|---|
Albert Einstein College of Medicine | Bronx, New York 10461 |
Johns Hopkins University | Baltimore, Maryland 21205 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Loyola University Medical Center | Maywood, Illinois 60153 |
CentraCare Clinic | Saint Cloud, Minnesota 56303 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Boston Medical Center | Boston, Massachusetts 02118 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Puget Sound Oncology Consortium | Seattle, Washington 98109 |
Eastern Maine Medical Center | Bangor, Maine 04401 |
William Beaumont Hospital | Royal Oak, Michigan 48073 |
Broward General Medical Center | Fort Lauderdale, Florida 33316 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Weill Medical College of Cornell University | New York, New York 10021 |
Group Health Cooperative | Seattle, Washington 98112 |
Great Falls Clinic | Great Falls, Montana 59405 |
Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Lewistown Hospital | Lewistown, Pennsylvania 17044 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Siouxland Regional Cancer Center | Sioux City, Iowa 51101-1733 |
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 Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Eastern Montana Cancer Center | Miles City, Montana 59301 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
Harborview Medical Center | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Central Washington Hospital | Wenatchee, Washington 98801 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Memorial Hospital | Carthage, Illinois 62321 |
Swedish Covenant Hospital | Chicago, Illinois 60625 |
Mercy Hospital and Medical Center | Chicago, Illinois 60616 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Kewanee Hospital | Kewanee, Illinois 61443 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Proctor Hospital | Peoria, Illinois 61614 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
Genesis Medical Center - West Campus | Davenport, Iowa 52804 |
Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
Wilson Medical Center | Wilson, North Carolina 27893-3428 |
Mountainview Medical | Berlin, Vermont 05602 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Eureka Hospital | Eureka, Illinois 61530 |
Cancer Center of Kansas - Ottawa | Ottawa, Kansas 66067 |
Graham Hospital Association | Canton, Illinois 61520 |
Saint Joseph Medical Center | Joliet, Illinois 60435 |
Deerpath Medical Associates | Lake Forest, Illinois 60045 |
Pekin Hospital | Pekin, Illinois 61554 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Hospital District Sixth of Harper County | Anthony, Kansas 67003 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Longmont United Hospital | Longmont, Colorado 80501 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Washington Hospital Center | Washington, District of Columbia 20010 |
Memorial Medical Center | Springfield, Illinois 62781 |
Southeastern Medical Oncology Center | Goldsboro, North Carolina 27534 |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Independence Regional Health Center | Independence, Missouri 64050 |
Northwestern University | Chicago, Illinois 60611 |
University of Florida | Gainesville, Florida 32610-0277 |
Case Western Reserve University | Cleveland, Ohio 44106 |
University Of Vermont | Burlington,, Vermont 05403 |
Presbyterian - Saint Lukes Medical Center - Health One | Denver, Colorado 80218 |
Kaiser Permanente | Sacramento, California |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
Providence Hospital | Southfield, Michigan 48075 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Penn State Milton S Hershey Medical Center | Hershey, Pennsylvania 17033 |
OSF Saint Francis Medical Center | Peoria, Illinois 61637 |
The Medical Center of Aurora | Aurora, Colorado 80012 |
Penrose-Saint Francis Healthcare | Colorado Springs, Colorado 80907 |
Saint Anthony Central Hospital | Denver, Colorado 80204 |
Exempla Saint Joseph Hospital | Denver, Colorado 80218 |
Colorado Cancer Research Program CCOP | Denver, Colorado 80224-2522 |
Saint Mary's Hospital and Regional Medical Center | Grand Junction, Colorado 81502 |
Saint Mary Corwin Medical Center | Pueblo, Colorado 81004 |
Lombardi Comprehensive Cancer Center at Georgetown University | Washington, District of Columbia 20057 |
Evanston CCOP-NorthShore University HealthSystem | Evanston, Illinois 60201 |
Intercommunity Cancer Center | Galesburg, Illinois 61401 |
Hopedale Medical Complex - Hospital | Hopedale, Illinois 61747 |
Joliet Oncology-Hematology Associates Limited | Joliet, Illinois 60435 |
Midwest Center for Hematology Oncology | Joliet, Illinois 60432 |
North Shore Hematology Oncology | Libertyville, Illinois 60048 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
Illinois CancerCare-Ottawa Clinic | Ottawa, Illinois 61350 |
Ottawa Regional Hospital and Healthcare Center | Ottawa, Illinois 61350 |
Pekin Cancer Treatment Center | Pekin, Illinois 61554 |
Illinois Oncology Research Association CCOP | Peoria, Illinois 61615 |
Illinois CancerCare-Peoria | Peoria, Illinois 61615 |
Illinois Valley Hospital | Peru, Illinois 61354 |
Sarah Culbertson Memorial Hospital | Rushville, Illinois 62681 |
Hematology Oncology Associates of Illinois - Skokie | Skokie, Illinois 60076 |
Midwest Cancer Research Group Incorporated | Skokie, Illinois 60077 |
Edward H Kaplan MD and Associates | Skokie, Illinois 60076 |
Saint Margaret's Hospital | Spring Valley, Illinois 61362 |
Carle Clinic-Urbana Main | Urbana, Illinois 61801 |
Saint Joseph's Medical Center | South Bend, Indiana 46617 |
McFarland Clinic | Ames, Iowa 50010 |
Medical Oncology and Hematology Associates-West Des Moines | Clive, Iowa 50325 |
Genesis Medical Center - East Campus | Davenport, Iowa 52803 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Capitol | Des Moines, Iowa 50307 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Siouxland Hematology - Oncology Associates | Sioux City, Iowa 51101 |
Memorial Hospital of Arkansas City | Arkansas City, Kansas 67005 |
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 |
Stormont-Vail Regional Health Center | Topeka, Kansas 66604 |
Saint Francis Hospital and Medical Center - Topeka | Topeka, Kansas 66606 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Ochsner Clinic CCOP | New Orleans, Louisiana 70121 |
Kalamazoo Center for Medical Studies | Kalamazoo, Michigan 49008 |
Lakeland Hospital | St. Joseph, Michigan 49085 |
Medini, Eitan MD (UIA Investigator) | Alexandria, Minnesota 56308 |
Saint Mary's Medical Center | Duluth, Minnesota 55805 |
Miller-Dwan Hospital | Duluth, Minnesota 55805 |
Etzell, Paul S MD (UIA Investigator) | Fergus Falls, Minnesota 56537 |
Swenson, Wade II, MD (UIA Investigator) | Fergus Falls, Minnesota 56537 |
Saint Cloud Hospital | Saint Cloud, Minnesota 56303 |
Saint Luke's Cancer Institute | Kansas City, Missouri 64111 |
Liberty Radiation Oncology Clinic | Kansas City, Missouri 64116 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Deaconess Medical Center | Billings, Montana 59107 |
Billings Clinic | Billings, Montana 59107-7000 |
Internal Medicine of Bozeman | Bozeman, Montana 59715 |
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
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 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
Orange Regional Medical Center | Middletown, New York 10940 |
Wayne Memorial Hospital | Goldsboro, North Carolina 27534 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Scranton Hematology Oncology | Scranton, Pennsylvania 18510 |
Mercy Hospital | Scranton, Pennsylvania 18501 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Saint Joseph Hospital | Bellingham, Washington 98225 |
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 |
West Virginia University | Morgantown, West Virginia 26506 |
Sacred Heart Hospital | Eau Claire, Wisconsin 54701 |
Oconomowoc Memorial Hospital-ProHealth Care Inc | Oconomowoc, Wisconsin 53066-3896 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
Memorial Healthcare System - Joe DiMaggio Children's Hospital | Hollywood, Florida 33021 |
Northeast Georgia Cancer Care LLC | Athens, Georgia 30607 |
Jesse Brown Veterans Affairs Medical Center | Chicago, Illinois 60612 |
University of Tennessee - Knoxville | Knoxville, Tennessee 37920 |
Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami, Florida 33136 |
United General Hospital | Sedro-Woolley, Washington 98284 |
Georgia Health Sciences University | Augusta, Georgia 30912 |
Eastern Cooperative Oncology Group | Boston, Massachusetts 02215 |
Essentia Health Duluth Clinic CCOP | Duluth, Minnesota 55805 |
Community Howard Regional Health | Kokomo, Indiana 46904 |
Indiana University Health La Porte Hospital | La Porte, Indiana 46350 |
Saint Joseph Regional Medical Center - Mishawaka | Plymouth, Indiana 46544 |
Saint Francis Hospital - Wilmington | Wilmington, Delaware 19805 |
Illinois Cancer Specialists-Niles | Niles, Illinois 60714 |
Cancer Care Center of Terrebonne Center | Houma, Louisiana 70360 |