A Randomized Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) With Either CCI-779 (Temsirolimus; NSC-683864) or R115777 (Tipifarnib; NSC-702818) in Metastatic Melanoma
PRIMARY OBJECTIVES:
I. Compare the response rate (confirmed and unconfirmed and complete and partial) in
patients with unresectable stage IV malignant melanoma treated with sorafenib in combination
with either temsirolimus or tipifarnib.
II. Compare the 4-month progression-free survival rate of patients treated with these
regimens.
III. Compare the safety and tolerability of these regimens, with an emphasis on long-term
side effects and toxic effects, in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
metastatic (M) stage (M1a/b vs M1c). Patients are randomized to 1 of 2 treatment arms.
ARM I (reopened to accrual as of 8/15/2009): Patients receive oral sorafenib twice daily on
days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
ARM II (closed to accrual as of 8/15/2009): Patients receive oral sorafenib as in arm I and
oral tipifarnib twice daily on days 1-21.
In both arms, courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 3 years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate (Complete and Partial)
Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30fi decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.
Every 8 weeks until progression
No
Kim Margolin
Principal Investigator
Southwest Oncology Group
United States: Food and Drug Administration
NCI-2009-00774
NCT00281957
August 2007
Name | Location |
---|---|
Louisiana State University | New Orleans, Louisiana 70112-2282 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
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 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Henry Ford Hospital | Detroit, Michigan 48202 |
South Georgia Medical Center | Valdosta, Georgia 31603 |
Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
Virginia Piper Cancer Institute | Minneapolis, Minnesota 55407 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Boston Medical Center | Boston, Massachusetts 02118 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
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 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
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 |
Holland Community Hospital | Holland, Michigan 49423 |
Munson Medical Center | Traverse City, Michigan 49684 |
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 |
Harborview Medical Center | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Genesis Medical Center - West Campus | Davenport, Iowa 52804 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Mary Imogene Bassett Hospital | Cooperstown, New York 13326 |
Highland General Hospital | Oakland, California 94602 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
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 |
Northern Montana Hospital | Havre, Montana 59501 |
Adventist Medical Center | Portland, Oregon 97216 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Longmont United Hospital | Longmont, Colorado 80501 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Sutter Roseville Medical Center | Roseville, California 95661 |
Memorial Medical Center | Springfield, Illinois 62781 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Providence Medical Center | Kansas City, Kansas 66112 |
Independence Regional Health Center | Independence, Missouri 64050 |
East Bay Radiation Oncology Center | Castro Valley, California 94546 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
Larry G Strieff MD Medical Corporation | Oakland, California 94609 |
El Camino Hospital | Mountain View, California 94040 |
Wayne State University | Detroit, Michigan 48202 |
Presbyterian - Saint Lukes Medical Center - Health One | Denver, Colorado 80218 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
Thomas Jefferson University Hospital | Philadelphia, Pennsylvania 19131 |
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 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Hays Medical Center | Hays, Kansas 67601 |
Valley Medical Oncology Consultants-Castro Valley | Castro Valley, California 94546 |
Eden Hospital Medical Center | Castro Valley, California 94546 |
Valley Medical Oncology Consultants-Fremont | Fremont, California 94538 |
Bay Area Breast Surgeons Inc | Oakland, California 94609 |
Bay Area Tumor Institution CCOP | Oakland, California 94609 |
Tom K Lee Inc | Oakland, California 94609 |
Valley Medical Oncology Consultants | Pleasanton, California 94588 |
Valley Care Health System - Pleasanton | Pleasanton, California 94588 |
Sutter General Hospital | Sacramento, California 95816 |
Doctors Medical Center- JC Robinson Regional Cancer Center | San Pablo, California 94806 |
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 |
Cancer Centers of Central Florida PA | Leesburg, Florida 34788 |
Rush - Copley Medical Center | Aurora, Illinois 60504 |
Joliet Oncology-Hematology Associates Limited | Joliet, Illinois 60435 |
Stoffel, Thomas J MD (UIA Investigator) | Moline, Illinois 61265 |
Garneau, Stewart C MD (UIA Investigator) | Moline, Illinois 61265 |
Sharis, Christine M MD (UIA Investigator) | Moline, Illinois 61265 |
Porubcin, Michael MD (UIA Investigator) | Moline, Illinois 61265 |
Carle Clinic-Urbana Main | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Center | Michigan City, Indiana 46360 |
McFarland Clinic | Ames, Iowa 50010 |
Constantinou, Costas L MD (UIA Investigator) | Bettendorf, Iowa 52722 |
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 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Radiation Oncology Practice Corporation Southwest | Overland Park, Kansas 66210 |
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 |
Louisiana State University Sciences Center- Monroe | Monroe, Louisiana 71210 |
Highland Clinic | Shreveport, Louisiana 71105 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan 49503 |
Mercy Health Partners-Mercy Campus | Muskegon, Michigan 49443 |
Mercy Health Partners-Hackley Campus | Muskegon, Michigan 49442 |
Southeast Missouri Hospital | Cape Girardeau, Missouri 63701 |
Radiation Oncology Practice Corporation - North | Kansas City, Missouri 64154 |
Radiation Oncology Practice Corporation South | 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 |
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
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 |
Good Samaritan Hospital | Kearney, Nebraska 68847 |
Lincoln Medical Education Foundation Cancer Resource Center | Lincoln, Nebraska 68510 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
Orange Regional Medical Center | Middletown, New York 10940 |
Mission Hospitals Inc | Asheville, North Carolina 28801 |
Mansfield General Hospital-MedCentral Health System | Mansfield, Ohio 44903 |
AnMed Health Hospital | Anderson, South Carolina 29621 |
Upstate Carolina CCOP | Spartanburg, South Carolina 29303 |
Southwest VA Regional Cancer Center | Norton, Virginia 24273 |
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 |
Dean Hematology and Oncology Clinic | Madison, Wisconsin 53717 |
Olathe Cancer Center | Olathe, Kansas 66061 |
University of Michigan University Hospital | Ann Arbor, Michigan 48109 |
Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
United General Hospital | Sedro-Woolley, Washington 98284 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
Carle Foundation - Carle Cancer Center | Urbana, Illinois 61801 |
Southwest Oncology Group | San Antonio, Texas 78245 |
PeaceHealth Saint Joseph Medical Center | Bellingham, Washington 98225 |
Bronson Battle Creek | Battle Creek, Michigan 49017 |
Promise Regional Medical Center-Hutchinson | Hutchinson, Kansas 65702 |