Spots Global Cancer Trial Database for Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by Surgery
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Trial Identification
Brief Title: Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by Surgery
Official Title: Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination With Erlotinib in Papillary Renal Cell Carcinoma
Study ID: NCT01688973
Study Description
Brief Summary: This randomized phase II trial studies how well tivantinib with or without erlotinib hydrochloride works in treating patients with metastatic or locally advanced kidney cancer that cannot be removed by surgery. Tivantinib and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. To assess the response rate (confirmed complete and partial response) of patients with locally advanced or metastatic papillary renal cell carcinoma treated with either ARQ 197 (tivantinib) or ARQ 197 combined with erlotinib (erlotinib hydrochloride). SECONDARY OBJECTIVES: I. To assess the progression free survival (PFS) of patients with locally advanced or metastatic papillary renal cell carcinoma treated with either ARQ 197 or ARQ 197 combined with erlotinib. II. To assess the safety and tolerability of ARQ 197 therapy and ARQ 197 combined with erlotinib. III. To descriptively assess the role of prior treatment on outcome. TERTIARY OBJECTIVES: I. To bank tissue specimens for future use and once funding is obtained to evaluate the expression of tissue correlative biomarkers such as hepatocyte growth factor receptor (c-MET) and epidermal growth factor receptor (EGFR), and to perform exploratory correlation with clinical outcomes. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive tivantinib orally (PO) twice daily (BID) on days 1-28. ARM II: Patients receive tivantinib PO BID and erlotinib hydrochloride PO once daily (QD) on days 1-28. 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 up every 3 months for 1 year and then every 6 months for up to 2 years.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona Cancer Center-Orange Grove Campus, Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States
The University of Arizona Medical Center-University Campus, Tucson, Arizona, United States
Kaiser Permanente-Anaheim, Anaheim, California, United States
Kaiser Permanente-Baldwin Park, Baldwin Park, California, United States
Kaiser Permanente-Bellflower, Bellflower, California, United States
Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, United States
Mills-Peninsula Medical Center, Burlingame, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Kaiser Permanente Hospital, Fontana, California, United States
Kaiser Permanente - Harbor City, Harbor City, California, United States
Kaiser Permanente-Irvine, Irvine, California, United States
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
Los Angeles County-USC Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Kaiser Permanente-Cadillac, Los Angeles, California, United States
Cedars Sinai Medical Center, Los Angeles, California, United States
Fremont - Rideout Cancer Center, Marysville, California, United States
Sutter Cancer Research Consortium, Novato, California, United States
Stanford Cancer Institute, Palo Alto, California, United States
Kaiser Permanente - Panorama City, Panorama City, California, United States
Kaiser Permanente-Riverside, Riverside, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
Kaiser Permanente-San Diego Mission, San Diego, California, United States
Kaiser Permanente-San Diego Zion, San Diego, California, United States
California Pacific Medical Center-Pacific Campus, San Francisco, California, United States
Kaiser Permanente-San Marcos, San Marcos, California, United States
Sutter Pacific Medical Foundation, Santa Rosa, California, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center, Truckee, California, United States
Sutter Solano Medical Center/Cancer Center, Vallejo, California, United States
Kaiser Permanente, Woodland Hills, California, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, Colorado, United States
Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Sibley Memorial Hospital, Washington, District of Columbia, United States
George Washington University Medical Center, Washington, District of Columbia, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
Idaho Urologic Institute-Meridian, Meridian, Idaho, United States
Hematology and Oncology Associates, Chicago, Illinois, United States
Northwestern University, Chicago, Illinois, United States
Hematology Oncology Associates of Illinois-Highland Park, Highland Park, Illinois, United States
Hines Veterans Administration Hospital, Hines, Illinois, United States
Presence Saint Mary's Hospital, Kankakee, Illinois, United States
NorthShore Hematology Oncology-Libertyville, Libertyville, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Illinois Cancer Specialists-Niles, Niles, Illinois, United States
Hematology Oncology Associates of Illinois - Skokie, Skokie, Illinois, United States
Franciscan Saint Francis Health-Beech Grove, Beech Grove, Indiana, United States
Franciscan Health Indianapolis, Indianapolis, Indiana, United States
Reid Health, Richmond, Indiana, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, 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
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
Saint Rose Ambulatory and Surgery Center, Great Bend, Kansas, United States
Hays Medical Center, Hays, Kansas, United States
Hutchinson Regional Medical Center, Hutchinson, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
Providence Medical Center, Kansas City, Kansas, United States
University of Kansas Cancer 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-Liberal, Liberal, Kansas, United States
Cancer Center of Kansas - McPherson, McPherson, Kansas, United States
Cancer Center of Kansas - Newton, Newton, Kansas, United States
Menorah Medical Center, Overland Park, Kansas, United States
Saint Luke's South Hospital, Overland Park, Kansas, United States
Cancer Center of Kansas - Parsons, Parsons, Kansas, United States
Via Christi Hospital-Pittsburg, Pittsburg, Kansas, United States
Kansas City NCI Community Oncology Research Program, Prairie Village, Kansas, United States
Cancer Center of Kansas - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas - Salina, Salina, Kansas, United States
Salina Regional Health Center, Salina, 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 - Wichita, Wichita, Kansas, United States
Via Christi Regional Medical Center, Wichita, Kansas, United States
Wichita NCI Community Oncology Research Program, Wichita, Kansas, United States
Cancer Center of Kansas - Winfield, Winfield, Kansas, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Beaumont Hospital-Dearborn, Dearborn, Michigan, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Saint John Hospital and Medical Center, Detroit, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus, Flint, Michigan, United States
Genesys Regional Medical Center, Grand Blanc, Michigan, United States
Allegiance Health, Jackson, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Sparrow Hospital, Lansing, Michigan, United States
Saint Mary Mercy Hospital, Livonia, Michigan, United States
Saint Joseph Mercy Oakland, Pontiac, Michigan, United States
Lake Huron Medical Center, Port Huron, Michigan, United States
Saint Mary's of Michigan, Saginaw, Michigan, United States
Saint John Macomb-Oakland Hospital, Warren, Michigan, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy Hospital, Coon Rapids, 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
New Ulm Medical Center, New Ulm, Minnesota, United States
North Memorial Medical Health Center, Robbinsdale, 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
University of Mississippi Medical Center, Jackson, Mississippi, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Truman Medical Center, Kansas City, Missouri, United States
Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States
North Kansas City Hospital, 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
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
Saint Louis-Cape Girardeau CCOP, Saint Louis, Missouri, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
University Medical Center of Southern Nevada, Las Vegas, Nevada, United States
Nevada Cancer Research Foundation CCOP, Las Vegas, Nevada, United States
Veterans Adminstration New Jersey Health Care System, East Orange, New Jersey, United States
Glens Falls Hospital, Glens Falls, New York, United States
Orange Regional Medical Center, Middletown, New York, United States
Columbia University/Herbert Irving Cancer Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
Kinston Medical Specialists PA, Kinston, North Carolina, United States
Iredell Memorial Hospital, Statesville, North Carolina, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Columbus NCI Community Oncology Research Program, Columbus, Ohio, United States
Grant Medical Center, Columbus, Ohio, United States
The Mark H Zangmeister Center, Columbus, Ohio, United States
Mount Carmel Health Center West, Columbus, Ohio, United States
Doctors Hospital, Columbus, Ohio, United States
Grandview Hospital, Dayton, Ohio, United States
Good Samaritan Hospital - Dayton, Dayton, Ohio, United States
Miami Valley Hospital, Dayton, Ohio, United States
Samaritan North Health Center, Dayton, Ohio, United States
Dayton NCI Community Oncology Research Program, Dayton, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Blanchard Valley Hospital, Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States
Wayne Hospital, Greenville, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
Saint Rita's Medical Center, Lima, Ohio, United States
Marietta Memorial Hospital, Marietta, Ohio, United States
Knox Community Hospital, Mount Vernon, Ohio, United States
Licking Memorial Hospital, Newark, Ohio, United States
Southern Ohio Medical Center, Portsmouth, Ohio, United States
Springfield Regional Medical Center, Springfield, Ohio, United States
Upper Valley Medical Center, Troy, Ohio, United States
Saint Ann's Hospital, Westerville, Ohio, United States
Greene Memorial Hospital, Xenia, Ohio, United States
Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Geisinger Medical Group, State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
Baylor University Medical Center, Dallas, Texas, United States
Audie L Murphy Veterans Affairs Hospital, San Antonio, Texas, United States
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio, San Antonio, Texas, United States
University Hospital, San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Cancer Care Center at Island Hospital, Anacortes, Washington, United States
PeaceHealth Saint Joseph Medical Center, Bellingham, Washington, United States
Harrison HealthPartners Hematology and Oncology-Bremerton, Bremerton, Washington, United States
Highline Medical Center-Main Campus, Burien, Washington, United States
Swedish Medical Center-Edmonds, Edmonds, Washington, United States
Swedish Cancer Institute-Issaquah, Issaquah, Washington, United States
Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States
Skagit Valley Hospital, Mount Vernon, Washington, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo, Poulsbo, Washington, United States
Harborview Medical Center, Seattle, Washington, United States
Minor and James Medical PLLC, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Group Health Cooperative-Seattle, Seattle, Washington, United States
Swedish Medical Center-First Hill, 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
Evergreen Hematology and Oncology PS, Spokane, Washington, United States
Wenatchee Valley Hospital and Clinics, Wenatchee, Washington, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
Contact Details
Name: Przemyslaw Twardowski
Affiliation: SWOG Cancer Research Network
Role: PRINCIPAL_INVESTIGATOR
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