Spots Global Cancer Trial Database for Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
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Trial Identification
Brief Title: Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
Official Title: Phase I/II Trial of IMC-A12 in Combination With Temsirolimus in Patients With Metastatic Breast Cancer
Study ID: NCT00699491
Study Description
Brief Summary: This phase I/II trial is studying the side effects and best dose of cixutumumab when given together with temsirolimus and to see how well they work in treating patients with breast cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other places in the body. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways by targeting certain cells. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with temsirolimus may be a better treatment for breast cancer.
Detailed Description: PRIMARY OBJECTIVES: I. To establish the recommended dose level for the phase II trial. (Phase I) II. To examine the safety profile of this combination in patients with metastatic breast cancer. (Phase I) III. To assess the anti-tumor activity (in terms of overall response rate) and toxicity profile of IMC-A12 (cixutumumab) in combination with temsirolimus in patients with metastatic breast cancer. (Phase II) SECONDARY OBJECTIVES: I. To estimate the progression-free survival (PFS) and overall survival distributions (as well as the 6-month PFS rate). II. To evaluate the in vivo mechanisms of action of temsirolimus in combination with IMC-A12 and to examine potential biomarker predictors of treatment response. OUTLINE: This is a phase I, dose-escalation study of cixutumumab followed by a phase II study. Patients receive temsirolimus intravenously (IV) over 30 minutes and cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 (cixutumumab is given on days 8, 15, and 22 of course 1 only). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for up to 2 (phase I) or 5 (phase II) years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Palo Alto Medical Foundation Health Care, Palo Alto, California, United States
Valley Medical Oncology Consultants, Pleasanton, 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
Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States
SCL Health Saint Joseph Hospital, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
Colorado Cancer Research Program NCORP, Denver, Colorado, United States
Swedish Medical Center, Englewood, 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
SCL Health Lutheran Medical Center, Wheat Ridge, Colorado, United States
Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States
Beebe Medical Center, Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Florida Hospital Orlando, Orlando, Florida, United States
John B Amos Cancer Center, Columbus, Georgia, United States
Hawaii Oncology Inc-Pali Momi, 'Aiea, Hawaii, United States
Pali Momi Medical Center, 'Aiea, Hawaii, United States
Hawaii Cancer Care Inc-POB II, Honolulu, Hawaii, United States
Queen's Medical Center, Honolulu, Hawaii, United States
Straub Clinic and Hospital, Honolulu, Hawaii, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Hawaii Oncology Inc-Kuakini, Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Castle Medical Center, Kailua, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
Rush - Copley Medical Center, Aurora, Illinois, United States
Saint Joseph Medical Center, Bloomington, Illinois, United States
Illinois CancerCare-Bloomington, Bloomington, Illinois, United States
Graham Hospital Association, Canton, Illinois, United States
Illinois CancerCare-Canton, Canton, Illinois, United States
Illinois CancerCare-Carthage, Carthage, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Weiss Memorial Hospital, Chicago, Illinois, United States
Heartland Cancer Research NCORP, Decatur, Illinois, United States
Eureka Hospital, Eureka, Illinois, United States
Illinois CancerCare-Eureka, Eureka, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Illinois CancerCare-Havana, Havana, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States
Illinois CancerCare-Macomb, Macomb, Illinois, United States
Mcdonough District Hospital, Macomb, Illinois, United States
Holy Family Medical Center, Monmouth, Illinois, United States
Illinois CancerCare-Monmouth, Monmouth, Illinois, United States
Bromenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center Foundation, Normal, Illinois, United States
Illinois CancerCare-Community Cancer Center, Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center, Ottawa, Illinois, United States
Illinois CancerCare-Pekin, Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center, Pekin, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF Saint Francis Medical Center, Peoria, Illinois, United States
Illinois CancerCare-Peru, Peru, Illinois, United States
Illinois Valley Hospital, Peru, Illinois, United States
Illinois CancerCare-Princeton, Princeton, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
Illinois CancerCare-Spring Valley, Spring Valley, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Franciscan Health Indianapolis, Indianapolis, Indiana, United States
Reid Health, Richmond, Indiana, 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
Union Hospital of Cecil County, Elkton, Maryland, United States
Bixby Medical Center, Adrian, Michigan, United States
Hickman Cancer Center, Adrian, Michigan, United States
Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Beaumont Hospital-Dearborn, Dearborn, Michigan, United States
Saint John Hospital and Medical Center, Detroit, Michigan, United States
Green Bay Oncology - Escanaba, Escanaba, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus, Flint, Michigan, United States
Green Bay Oncology - Iron Mountain, Iron Mountain, Michigan, United States
Allegiance Health, Jackson, Michigan, United States
Sparrow Hospital, Lansing, Michigan, United States
Saint Mary Mercy Hospital, Livonia, Michigan, United States
Mercy Memorial Hospital, Monroe, Michigan, United States
Toledo Clinic Cancer Centers-Monroe, Monroe, 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
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
Mayo Clinic, Rochester, Minnesota, United States
Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud, Minnesota, United States
Saint Cloud Hospital, Saint Cloud, Minnesota, 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
Saint Joseph Oncology Inc, Saint Joseph, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States
Nebraska Cancer Research Center, Lincoln, Nebraska, United States
Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center, Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, United States
Alegent Health Lakeside Hospital, Omaha, Nebraska, United States
Creighton University Medical Center, Omaha, Nebraska, United States
Cooper Hospital University Medical Center, Camden, New Jersey, United States
Glens Falls Hospital, Glens Falls, New York, United States
Randolph Hospital, Asheboro, North Carolina, United States
Wayne Memorial Hospital, Goldsboro, North Carolina, United States
Cone Health Cancer Center, Greensboro, North Carolina, United States
Margaret R Pardee Memorial Hospital, Hendersonville, North Carolina, United States
Annie Penn Memorial Hospital, Reidsville, North Carolina, United States
Mid Dakota Clinic, Bismarck, North Dakota, United States
Saint Alexius Medical Center, Bismarck, North Dakota, United States
Sanford Bismarck Medical Center, Bismarck, North Dakota, United States
Altru Cancer Center, Grand Forks, North Dakota, United States
Toledo Clinic Cancer Centers-Bowling Green, Bowling Green, Ohio, 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
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
Hematology Oncology Center Incorporated, Elyria, Ohio, United States
Mercy Cancer Center-Elyria, Elyria, 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
Lima Memorial Hospital, Lima, Ohio, United States
Marietta Memorial Hospital, Marietta, Ohio, United States
Toledo Clinic Cancer Centers-Maumee, Maumee, Ohio, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center, Maumee, Ohio, United States
Knox Community Hospital, Mount Vernon, Ohio, United States
Licking Memorial Hospital, Newark, Ohio, United States
Saint Charles Hospital, Oregon, Ohio, United States
Toledo Clinic Cancer Centers-Oregon, Oregon, Ohio, United States
Southern Ohio Medical Center, Portsmouth, Ohio, United States
Springfield Regional Medical Center, Springfield, Ohio, United States
Flower Hospital, Sylvania, Ohio, United States
Mercy Hospital of Tiffin, Tiffin, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital, Toledo, Ohio, United States
Saint Vincent Mercy Medical Center, Toledo, Ohio, United States
University of Toledo, Toledo, Ohio, United States
Toledo Community Hospital Oncology Program CCOP, Toledo, Ohio, United States
Mercy Saint Anne Hospital, Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States
Upper Valley Medical Center, Troy, Ohio, United States
Fulton County Health Center, Wauseon, 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
Natalie Warren Bryant Cancer Center at Saint Francis, Tulsa, Oklahoma, United States
Legacy Mount Hood Medical Center, Gresham, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center, Portland, Oregon, United States
Legacy Meridian Park Hospital, Tualatin, Oregon, United States
Fredericksburg Oncology Inc, Fredericksburg, Virginia, United States
Legacy Salmon Creek Hospital, Vancouver, 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
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Holy Family Memorial Hospital, Manitowoc, Wisconsin, United States
Bay Area Medical Center, Marinette, Wisconsin, United States
Green Bay Oncology - 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
Contact Details
Name: Cynthia Ma
Affiliation: Alliance for Clinical Trials in Oncology
Role: PRINCIPAL_INVESTIGATOR
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