Spots Global Cancer Trial Database for Pixantrone Dimaleate in Treating Patients With HER2-Negative Metastatic Breast Cancer
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Trial Identification
Brief Title: Pixantrone Dimaleate in Treating Patients With HER2-Negative Metastatic Breast Cancer
Official Title: Randomized Phase II Study of Two Doses of Pixantrone in Patients With Metastatic Breast Cancer
Study ID: NCT01086605
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as pixantrone dimaleate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pixantrone dimaleate in different ways may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well pixantrone dimaleate works in treating patients with HER2-negative metastatic breast cancer.
Detailed Description: OBJECTIVES: Primary * To assess the proportion of confirmed tumor responses at each dose level of pixantrone Secondary * To describe the distribution of progression-free survival (PFS) times of patients receiving pixantrone * To assess the 6-month PFS rate in patients receiving each dose level of pixantrone * To describe the overall survival distribution of patients receiving pixantrone * To assess the adverse event profile of pixantrone in the treatment of patients with metastatic breast cancer. * To evaluate the quality of life and patient-reported symptoms of patients receiving the study regimen OUTLINE: This is a multicenter study. Patients are randomized according to prior doxorubicin treatment ( yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Some patients undergo blood sample collection at baseline and periodically during study for circulating tumor cells analysis by CellSearch System and mRNA isolation assays. Patients complete quality-of-life questionnaires using the Linear Analogue Self Assessment (LASA6) and the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at baseline and periodically during study. After completion of study therapy, patients are followed up every 3-6 months for up to 5 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Poudre Valley Hospital, Fort Collins, Colorado, United States
Front Range Cancer Specialists, Fort Collins, Colorado, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States
Kapiolani Medical Center at Pali Momi, 'Aiea, Hawaii, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Lusitana, Honolulu, Hawaii, United States
Queen's Cancer Institute at Queen's Medical Center, Honolulu, Hawaii, United States
Straub Clinic and Hospital, Incorporated, Honolulu, Hawaii, United States
Hawaii Medical Center - East, Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Kuakini, Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Kauai Medical Clinic, Lihue, Hawaii, United States
Maui Memorial Medical Center, Wailuku, Hawaii, United States
Pacific Cancer Institute - Maui, Wailuku, Hawaii, United States
Illinois CancerCare - Bloomington, Bloomington, Illinois, United States
St. Joseph Medical Center, Bloomington, Illinois, United States
Graham Hospital, Canton, Illinois, United States
Illinois CancerCare - Canton, Canton, Illinois, United States
Illinois CancerCare - Carthage, Carthage, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
Eureka Community Hospital, Eureka, Illinois, United States
Illinois CancerCare - Eureka, Eureka, Illinois, United States
Galesburg Clinic, PC, Galesburg, Illinois, United States
Illinois CancerCare - Galesburg, Galesburg, 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
Illinois CancerCare - Monmouth, Monmouth, Illinois, United States
BroMenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center, Normal, Illinois, United States
Illinois CancerCare - Community Cancer Center, Normal, Illinois, United States
Community Hospital of Ottawa, Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, United States
Illinois CancerCare - Pekin, Pekin, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF St. Francis Medical Center, Peoria, Illinois, United States
Illinois CancerCare - Peru, Peru, Illinois, United States
Illinois Valley Community 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
CCOP - Carle Cancer Center, Urbana, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana, United States
Elkhart Clinic, LLC, Elkhart, Indiana, United States
Michiana Hematology-Oncology, PC - Elkhart, Elkhart, Indiana, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Howard Community Hospital, Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend, Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center, Mishawaka, Indiana, United States
Michiana Hematology Oncology PC - Plymouth, Plymouth, Indiana, United States
Reid Hospital & Health Care Services, Richmond, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
South Bend Clinic, South Bend, Indiana, United States
Michiana Hematology Oncology PC - La Porte, Westville, Indiana, United States
McFarland Clinic, PC, Ames, Iowa, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center, Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines, Clive, Iowa, United States
Mercy Cancer Center - West Lakes, Clive, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa, Mason City, Iowa, United States
McCreery Cancer Center at Ottumwa Regional, Ottumwa, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa, United States
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
Methodist West Hospital, West Des Moines, Iowa, United States
Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Dickinson County Healthcare System, Iron Mountain, Michigan, United States
Foote Memorial Hospital, Jackson, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
St. Mary Mercy Hospital, Livonia, Michigan, United States
Community Cancer Center of Monroe, Monroe, Michigan, United States
Mercy Memorial Hospital - Monroe, Monroe, Michigan, United States
Michiana Hematology Oncology PC - Niles, Niles, Michigan, United States
St. Joseph Mercy Oakland, Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
MeritCare Bemidji, Bemidji, Minnesota, United States
St. Joseph's Medical Center, Brainerd, Minnesota, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
Duluth Clinic Cancer Center - Duluth, Duluth, Minnesota, United States
CCOP - Duluth, Duluth, Minnesota, United States
Miller - Dwan Medical Center, Duluth, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood, Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center, Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center, Shakopee, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Willmar Cancer Center at Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota, United States
Goldschmidt Cancer Center, Jefferson City, Missouri, United States
Missouri Baptist Cancer Center, Saint Louis, Missouri, United States
Comprehensive Cancer Care, PC, Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
St. John's Regional Health Center, Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States
Billings Clinic - Downtown, Billings, Montana, United States
Bozeman Deaconess Cancer Center, Bozeman, Montana, United States
St. James Healthcare Cancer Care, Butte, Montana, United States
Big Sky Oncology, Great Falls, Montana, United States
Great Falls Clinic - Main Facility, Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States
Northern Montana Hospital, Havre, Montana, United States
St. Peter's Hospital, Helena, Montana, United States
Glacier Oncology, PLLC, Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States
Lovelace Medical Center - Downtown, Albuquerque, New Mexico, United States
Hematology Oncology Associates, PC, Albuquerque, New Mexico, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
University of New Mexico Cancer Center - South, Las Cruces, New Mexico, United States
Rutherford Hospital, Rutherfordton, North Carolina, United States
CCOP - MeritCare Hospital, Fargo, North Dakota, United States
MeritCare Broadway, Fargo, North Dakota, United States
Mary Rutan Hospital, Bellefontaine, Ohio, United States
Wood County Oncology Center, Bowling Green, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
North Coast Cancer Care - Clyde, Clyde, Ohio, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Grant Medical Center Cancer Care, Columbus, Ohio, United States
Mount Carmel Health - West Hospital, Columbus, Ohio, United States
Doctors Hospital at Ohio Health, Columbus, Ohio, United States
Grandview Hospital, Dayton, Ohio, United States
Good Samaritan Hospital, Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States
Samaritan North Cancer Care Center, Dayton, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Community Cancer Center, Elyria, Ohio, United States
Hematology Oncology Center, Elyria, Ohio, United States
Blanchard Valley Medical Associates, Findlay, Ohio, United States
Middletown Regional Hospital, Franklin, Ohio, United States
Wayne Hospital, Greenville, Ohio, United States
Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
Lima Memorial Hospital, Lima, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio, United States
Northwest Ohio Oncology Center, Maumee, Ohio, United States
St. Luke's Hospital, Maumee, Ohio, United States
Knox Community Hospital, Mount Vernon, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio, United States
Fisher-Titus Medical Center, Norwalk, Ohio, United States
St. Charles Mercy Hospital, Oregon, Ohio, United States
Toledo Clinic - Oregon, Oregon, Ohio, United States
North Coast Cancer Care, Incorporated, Sandusky, Ohio, United States
Community Hospital of Springfield and Clark County, Springfield, Ohio, United States
Flower Hospital Cancer Center, Sylvania, Ohio, United States
Mercy Hospital of Tiffin, Tiffin, Ohio, United States
Toledo Hospital, Toledo, Ohio, United States
St. Vincent Mercy Medical Center, Toledo, Ohio, United States
Medical University of Ohio Cancer Center, Toledo, Ohio, United States
CCOP - Toledo Community Hospital, Toledo, Ohio, United States
St. Anne Mercy Hospital, Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic, Toledo, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States
Fulton County Health Center, Wauseon, Ohio, United States
Mount Carmel St. Ann's Cancer Center, Westerville, Ohio, United States
Clinton Memorial Hospital, Wilmington, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States
Genesis - Good Samaritan Hospital, Zanesville, Ohio, United States
Clackamas Radiation Oncology Center, Clackamas, Oregon, United States
Providence Milwaukie Hospital, Milwaukie, Oregon, United States
Providence Newberg Medical Center, Newberg, Oregon, United States
Willamette Falls Hospital, Oregon City, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon, United States
Adventist Medical Center, Portland, Oregon, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Providence St. Vincent Medical Center, Portland, Oregon, United States
Guthrie Cancer Center at Guthrie Clinic Sayre, Sayre, Pennsylvania, United States
AnMed Cancer Center, Anderson, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Medical X-Ray Center, PC, Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, United States
Fredericksburg Oncology, Incorporated, Fredericksburg, Virginia, United States
Southwest Washington Medical Center Cancer Center, Vancouver, Washington, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital, Huntington, West Virginia, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Holy Family Memorial Medical Center Cancer Care Center, Manitowoc, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin, United States
St. Nicholas Hospital, Sheboygan, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Rocky Mountain Oncology, Casper, Wyoming, United States
Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States
Contact Details
Name: Alvaro Moreno-Asptia, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
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