Spots Global Cancer Trial Database for Sorafenib With Either Temsirolimus or Tipifarnib in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed By Surgery
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Trial Identification
Brief Title: Sorafenib With Either Temsirolimus or Tipifarnib in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed By Surgery
Official Title: 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
Study ID: NCT00281957
Study Description
Brief Summary: This randomized phase II trial is studying how well giving sorafenib together with either temsirolimus or tipifarnib works in treating patients with stage IV melanoma that cannot be removed by surgery. Sorafenib, temsirolimus, and tipifarnib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib and tipifarnib may also stop the growth of tumor by blocking blood flow to the tumor. It is not yet known whether sorafenib is more effective when given together with temsirolimus or tipifarnib in treating patients with malignant melanoma.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
East Bay Radiation Oncology Center, Castro Valley, California, United States
Eden Hospital Medical Center, Castro Valley, California, United States
Valley Medical Oncology Consultants-Castro Valley, Castro Valley, California, United States
Valley Medical Oncology Consultants-Fremont, Fremont, California, United States
University of Southern California/Norris Cancer Center, Los Angeles, California, United States
Contra Costa Regional Medical Center, Martinez, California, United States
El Camino Hospital, Mountain View, California, United States
Highland General Hospital, Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus, Oakland, California, United States
Bay Area Breast Surgeons Inc, Oakland, California, United States
Bay Area Tumor Institute CCOP, Oakland, California, United States
Larry G Strieff MD Medical Corporation, Oakland, California, United States
Tom K Lee Inc, Oakland, California, United States
Valley Care Health System - Pleasanton, Pleasanton, California, United States
Valley Medical Oncology Consultants, Pleasanton, California, United States
Sutter Roseville Medical Center, Roseville, California, United States
Sutter General Hospital, Sacramento, California, United States
Doctors Medical Center- JC Robinson Regional Cancer Center, San Pablo, California, United States
The Medical Center of Aurora, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Exempla Saint Joseph Hospital, Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
Colorado Cancer Research Program CCOP, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Saint Mary's Hospital and Regional Medical Center, Grand Junction, Colorado, United States
North Colorado Medical Center, Greeley, Colorado, United States
Saint Anthony Hospital, Lakewood, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Longmont United Hospital, Longmont, Colorado, United States
McKee Medical Center, Loveland, Colorado, United States
Saint Mary Corwin Medical Center, Pueblo, Colorado, United States
North Suburban Medical Center, Thornton, Colorado, United States
Exempla Lutheran Medical Center, Wheat Ridge, Colorado, United States
Cancer Centers of Central Florida PA, Leesburg, Florida, United States
Northeast Georgia Medical Center, Gainesville, Georgia, United States
Memorial Health University Medical Center, Savannah, Georgia, United States
South Georgia Medical Center, Valdosta, Georgia, United States
Rush - Copley Medical Center, Aurora, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Joliet Oncology-Hematology Associates Limited, Joliet, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Garneau, Stewart C MD (UIA Investigator), Moline, Illinois, United States
Porubcin, Michael MD (UIA Investigator), Moline, Illinois, United States
Sharis, Christine M MD (UIA Investigator), Moline, Illinois, United States
Stoffel, Thomas J MD (UIA Investigator), Moline, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Carle Clinic-Urbana Main, Urbana, Illinois, United States
Franciscan Saint Anthony Health-Michigan City, Michigan City, Indiana, United States
McFarland Clinic PC-William R Bliss Cancer Center, Ames, Iowa, United States
Constantinou, Costas L MD (UIA Investigator), Bettendorf, Iowa, United States
Medical Oncology and Hematology Associates-West Des Moines, Clive, Iowa, United States
Genesis Medical Center - East Campus, Davenport, Iowa, United States
Genesis Medical Center - West Campus, Davenport, Iowa, United States
Mercy Capitol, Des Moines, Iowa, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Iowa Oncology Research Association CCOP, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
Iowa Lutheran Hospital, Des Moines, Iowa, United States
Siouxland Hematology Oncology Associates, Sioux City, Iowa, United States
Mercy Medical Center-Sioux City, Sioux City, Iowa, United States
Saint Luke's Regional Medical Center, Sioux City, Iowa, United States
Hospital District Sixth of Harper County, Anthony, Kansas, United States
Cancer Center of Kansas - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States
Hays Medical Center, Hays, Kansas, United States
Promise Regional Medical Center-Hutchinson, Hutchinson, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
Providence Medical Center, Kansas City, Kansas, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Cancer Center of Kansas-Kingman, Kingman, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Cancer Center of Kansas - Newton, Newton, Kansas, United States
Olathe Cancer Center, Olathe, Kansas, United States
Radiation Oncology Practice Corporation Southwest, Overland Park, Kansas, United States
Cancer Center of Kansas - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas - Salina, Salina, Kansas, United States
Stormont-Vail Regional Health Center, Topeka, Kansas, United States
Saint Francis Hospital and Medical Center - Topeka, Topeka, Kansas, United States
Cancer Center of Kansas - Wellington, Wellington, Kansas, United States
Associates In Womens Health, Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas - Main Office, Wichita, Kansas, United States
Via Christi Regional Medical Center, Wichita, Kansas, United States
Wichita CCOP, Wichita, Kansas, United States
Cancer Center of Kansas - Winfield, Winfield, Kansas, United States
Louisiana State University Sciences Center- Monroe, Monroe, Louisiana, United States
Highland Clinic, Shreveport, Louisiana, United States
Louisiana State University Health Sciences Center Shreveport, Shreveport, Louisiana, United States
Boston Medical Center, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Bronson Battle Creek, Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital, Big Rapids, Michigan, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, United States
Mercy Health Saint Mary's, Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States
Holland Community Hospital, Holland, Michigan, United States
Mercy Health Partners-Hackley Campus, Muskegon, Michigan, United States
Mercy Health Mercy Campus, Muskegon, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
Metro Health Hospital, Wyoming, Michigan, United States
Meeker County Memorial Hospital, Litchfield, Minnesota, United States
Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States
Southeast Missouri Hospital, Cape Girardeau, Missouri, United States
Centerpoint Medical Center LLC, Independence, Missouri, United States
Radiation Oncology Practice Corporation South, Kansas City, Missouri, United States
Radiation Oncology Practice Corporation - North, Kansas City, Missouri, United States
Montana Cancer Consortium CCOP, Billings, Montana, United States
Northern Rockies Radiation Oncology Center, Billings, Montana, United States
Saint Vincent Healthcare, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies PC, Billings, Montana, United States
Billings Clinic, Billings, Montana, United States
Bozeman Deaconess Cancer Center, Bozeman, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, United States
Berdeaux, Donald MD (UIA Investigator), Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Northern Montana Hospital, Havre, Montana, United States
Saint Peter's Community Hospital, Helena, Montana, United States
Glacier Oncology PLLC, Kalispell, Montana, United States
Kalispell Medical Oncology, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Community Medical Hospital, Missoula, Montana, United States
Montana Cancer Specialists, Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States
Guardian Oncology and Center for Wellness, Missoula, Montana, United States
Good Samaritan Hospital, Kearney, Nebraska, United States
Nebraska Cancer Research Center, Lincoln, Nebraska, United States
University Medical Center of Southern Nevada, Las Vegas, Nevada, United States
Nevada Cancer Research Foundation CCOP, Las Vegas, Nevada, United States
Mary Imogene Bassett Hospital, Cooperstown, New York, United States
Orange Regional Medical Center, Middletown, New York, United States
Mission Hospital-Memorial Campus, Asheville, North Carolina, United States
Rutherford Hospital, Rutherfordton, North Carolina, United States
University of Cincinnati, Cincinnati, Ohio, United States
Mansfield General Hospital-MedCentral Health System, Mansfield, Ohio, United States
Adventist Medical Center, Portland, Oregon, United States
SWOG, Portland, Oregon, United States
Delaware County Memorial Hospital, Drexel Hill, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
AnMed Health Hospital, Anderson, South Carolina, United States
Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Upstate Carolina CCOP, Spartanburg, South Carolina, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Danville Regional Medical Center, Danville, Virginia, United States
Southwest VA Regional Cancer Center, Norton, Virginia, United States
PeaceHealth Saint Joseph Medical Center, Bellingham, Washington, United States
Harrison HealthPartners Hematology and Oncology-Bremerton, Bremerton, Washington, United States
Columbia Basin Hematology and Oncology PLLC, Kennewick, Washington, United States
Skagit Valley Hospital, Mount Vernon, Washington, United States
Harborview Medical Center, Seattle, Washington, United States
Minor and James Medical PLLC, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States
Group Health Cooperative-Seattle, Seattle, Washington, United States
Swedish Medical Center-First Hill, Seattle, Washington, United States
The Polyclinic, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
United General Hospital, Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South, Spokane, Washington, United States
Wenatchee Valley Medical Center, Wenatchee, Washington, United States
Dean Hematology and Oncology Clinic, Madison, Wisconsin, United States
Welch Cancer Center, Sheridan, Wyoming, United States
Contact Details
Name: Kim Margolin
Affiliation: SWOG Cancer Research Network
Role: PRINCIPAL_INVESTIGATOR
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