Spots Global Cancer Trial Database for Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery
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Trial Identification
Brief Title: Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery
Official Title: Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma
Study ID: NCT01835145
Study Description
Brief Summary: This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye (ocular melanoma) that has spread to other parts of the body and cannot be removed by surgery. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cabozantinib-s-malate works better than temozolomide or dacarbazine in treating patients with melanoma of the eye.
Detailed Description: PRIMARY OBJECTIVES: I. Compare the progression-free survival rate at 4 months (PFS4) of patients with ocular melanoma treated with cabozantinib-s-malate (cabozantinib) or temozolomide (or dacarbazine). SECONDARY OBJECTIVES: I. Estimate the distribution of progression-free survival (PFS) times. II. Estimate the distribution of overall survival (OS) times. III. Estimate the confirmed response rate as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. IV. Assess the safety of these agents by examining the toxicity profile. V. Correlate the response of MET molecular status. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive temozolomide PO daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. If temozolomide is not available, patients receive dacarbazine intravenously (IV) over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks for 2 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Anchorage Radiation Therapy Center, Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States
Alaska Women's Cancer Care, Anchorage, Alaska, United States
Anchorage Oncology Centre, Anchorage, Alaska, United States
Katmai Oncology Group, Anchorage, Alaska, United States
Providence Alaska Medical Center, Anchorage, Alaska, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, United States
Beebe Medical Center, Lewes, Delaware, United States
Christiana Gynecologic Oncology LLC, Newark, Delaware, United States
Delaware Clinical and Laboratory Physicians PA, Newark, Delaware, United States
Helen F Graham Cancer Center, Newark, Delaware, United States
Medical Oncology Hematology Consultants PA, Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Beebe Health Campus, Rehoboth Beach, Delaware, United States
TidalHealth Nanticoke / Allen Cancer Center, Seaford, Delaware, United States
Christiana Care Health System-Wilmington Hospital, Wilmington, Delaware, United States
Holy Cross Hospital, Fort Lauderdale, Florida, United States
Jupiter Medical Center, Jupiter, Florida, United States
Mount Sinai Medical Center, Miami Beach, Florida, United States
Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States
Kootenai Health - Coeur d'Alene, Coeur d'Alene, Idaho, United States
Saint Luke's Cancer Institute - Fruitland, Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian, Meridian, Idaho, United States
Saint Luke's Cancer Institute - Nampa, Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, United States
Kootenai Cancer Clinic, Sandpoint, Idaho, United States
Saint Luke's Cancer Institute - Twin Falls, Twin Falls, Idaho, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Hematology Oncology Associates of Illinois-Highland Park, Highland Park, Illinois, United States
Presence Saint Mary's Hospital, Kankakee, Illinois, United States
AMG Libertyville - Oncology, Libertyville, 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
Spector, David MD (UIA Investigator), Moline, Illinois, United States
Trinity Medical Center, Moline, Illinois, United States
Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States
Illinois Cancer Specialists-Niles, Niles, Illinois, United States
Hematology Oncology Associates of Illinois - Skokie, Skokie, Illinois, United States
Mary Greeley Medical Center, Ames, Iowa, United States
McFarland Clinic PC - Ames, Ames, Iowa, United States
Constantinou, Costas L MD (UIA Investigator), Bettendorf, Iowa, United States
McFarland Clinic PC-Boone, Boone, Iowa, United States
McFarland Clinic PC-Trinity Cancer Center, Fort Dodge, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
McFarland Clinic PC-Jefferson, Jefferson, Iowa, United States
McFarland Clinic PC-Marshalltown, Marshalltown, Iowa, United States
Siouxland Regional Cancer Center, 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
Menorah Medical Center, Overland Park, Kansas, United States
Saint Luke's South Hospital, Overland Park, Kansas, United States
Kansas City NCI Community Oncology Research Program, Prairie Village, Kansas, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Bronson Battle Creek, Battle Creek, Michigan, United States
Green Bay Oncology - Escanaba, Escanaba, Michigan, United States
Cancer Research Consortium of West Michigan NCORP, 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
Green Bay Oncology - Iron Mountain, Iron Mountain, Michigan, United States
Mercy Health Mercy Campus, Muskegon, Michigan, United States
Lakeland Hospital Niles, Niles, Michigan, United States
Spectrum Health Reed City Hospital, Reed City, Michigan, United States
Lakeland Medical Center Saint Joseph, Saint Joseph, Michigan, United States
Marie Yeager Cancer Center, Saint Joseph, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Essentia Health Cancer Center, Duluth, Minnesota, United States
Essentia Health Saint Mary's Medical Center, Duluth, Minnesota, United States
Miller-Dwan Hospital, Duluth, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
Health Partners Inc, Minneapolis, Minnesota, United States
New Ulm Medical Center, New Ulm, Minnesota, United States
North Memorial Medical Health Center, Robbinsdale, Minnesota, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center, Shakopee, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States
Cox Cancer Center Branson, Branson, Missouri, United States
Centerpoint Medical Center LLC, Independence, Missouri, United States
Mercy Hospital Joplin, Joplin, Missouri, United States
Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States
Heartland Hematology and Oncology Associates Incorporated, Kansas City, Missouri, United States
Research Medical Center, Kansas City, Missouri, United States
Saint Luke's East - Lee's Summit, Lee's Summit, Missouri, United States
Liberty Radiation Oncology Center, Liberty, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States
Heartland Regional Medical Center, Saint Joseph, Missouri, United States
Saint Joseph Oncology Inc, Saint Joseph, Missouri, United States
Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Cancer Research for the Ozarks NCORP, Springfield, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Community Hospital of Anaconda, Anaconda, Montana, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Saint Vincent Healthcare, Billings, Montana, United States
Montana Cancer Consortium NCORP, Billings, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, United States
Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Saint Peter's Community Hospital, Helena, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States
Community Medical Hospital, Missoula, Montana, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Cancer and Blood Specialists-Henderson, Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada - Henderson, Henderson, Nevada, United States
Las Vegas Cancer Center-Henderson, Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson, Henderson, Nevada, United States
GenesisCare USA - Henderson, Henderson, Nevada, United States
University Medical Center of Southern Nevada, Las Vegas, Nevada, United States
Cancer and Blood Specialists-Shadow, Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Central, Las Vegas, Nevada, United States
GenesisCare USA - Las Vegas, Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway, Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-San Martin, Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Southeast, Las Vegas, Nevada, United States
Cancer Therapy and Integrative Medicine, Las Vegas, Nevada, United States
Cancer and Blood Specialists-Tenaya, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Northwest, Las Vegas, Nevada, United States
GenesisCare USA - Vegas Tenaya, Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-Tenaya, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas, Nevada, United States
Las Vegas Cancer Center-Medical Center, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
GenesisCare USA - Fort Apache, Las Vegas, Nevada, United States
OptumCare Cancer Care at Fort Apache, Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas, Nevada, United States
Nevada Cancer Research Foundation NCORP, Las Vegas, Nevada, United States
Morristown Medical Center, Morristown, New Jersey, United States
Overlook Hospital, Summit, New Jersey, United States
Duke University Medical Center, Durham, North Carolina, United States
Vidant Oncology-Kinston, Kinston, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
The Christ Hospital, Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States
Saint Charles Health System, Bend, Oregon, United States
Clackamas Radiation Oncology Center, Clackamas, Oregon, United States
Providence Cancer Institute Clackamas Clinic, Clackamas, Oregon, United States
Bay Area Hospital, Coos Bay, Oregon, United States
Providence Milwaukie Hospital, Milwaukie, Oregon, United States
Providence Newberg Medical Center, Newberg, Oregon, United States
Providence Willamette Falls Medical Center, Oregon City, Oregon, United States
Providence Portland Medical Center, Portland, Oregon, United States
Providence Saint Vincent Medical Center, Portland, Oregon, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Prisma Health Cancer Institute - Spartanburg, Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Easley, Easley, South Carolina, United States
Greenville Health System Cancer Institute-Andrews, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Butternut, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States
Prisma Health Greenville Memorial Hospital, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer, Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States
Bristol Regional Medical Center, Bristol, Tennessee, United States
Wellmont Medical Associates Oncology and Hematology-Johnson City, Johnson City, Tennessee, United States
Ballad Health Cancer Care - Kingsport, Kingsport, Tennessee, United States
Wellmont Holston Valley Hospital and Medical Center, Kingsport, Tennessee, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
Southwest VA Regional Cancer Center, Norton, Virginia, United States
Providence Regional Cancer System-Aberdeen, Aberdeen, Washington, United States
Cancer Care Center at Island Hospital, Anacortes, Washington, United States
Swedish Cancer Institute-Eastside Oncology Hematology, Bellevue, Washington, United States
PeaceHealth Saint Joseph Medical Center, Bellingham, Washington, United States
Providence Regional Cancer System-Centralia, Centralia, Washington, United States
Swedish Cancer Institute-Edmonds, Edmonds, Washington, United States
Providence Regional Cancer Partnership, Everett, Washington, United States
Swedish Cancer Institute-Issaquah, Issaquah, Washington, United States
Providence Regional Cancer System-Lacey, Lacey, Washington, United States
PeaceHealth Saint John Medical Center, Longview, Washington, United States
Minor and James Medical PLLC, Seattle, Washington, United States
Pacific Gynecology Specialists, Seattle, Washington, United States
Swedish Medical Center-Ballard Campus, Seattle, Washington, United States
Kaiser Permanente Washington, Seattle, Washington, United States
Swedish Medical Center-First Hill, Seattle, Washington, United States
Providence Regional Cancer System-Shelton, Shelton, Washington, United States
MultiCare Deaconess Cancer and Blood Specialty Center - Valley, Spokane Valley, Washington, United States
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown, Spokane, Washington, United States
PeaceHealth Southwest Medical Center, Vancouver, Washington, United States
Compass Oncology Vancouver, Vancouver, Washington, United States
Providence Saint Mary Regional Cancer Center, Walla Walla, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima, Washington, United States
Providence Regional Cancer System-Yelm, Yelm, Washington, United States
Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital, Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay, Wisconsin, United States
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Holy Family Memorial Hospital, Manitowoc, Wisconsin, United States
Bay Area Medical Center, Marinette, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Oconto Falls, Oconto Falls, Wisconsin, United States
HSHS Saint Nicholas Hospital, Sheboygan, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Rocky Mountain Oncology, Casper, Wyoming, United States
Big Horn Basin Cancer Center, Cody, Wyoming, United States
Billings Clinic-Cody, Cody, Wyoming, United States
Welch Cancer Center, Sheridan, Wyoming, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
CHUM - Hopital Notre-Dame, Montreal, Quebec, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Contact Details
Name: Jason J Luke
Affiliation: Alliance for Clinical Trials in Oncology
Role: PRINCIPAL_INVESTIGATOR
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