A Phase II Trial Of Trastuzumab Plus Weekly Ixabepilone (BMS-247550) And Carboplatin In Patients With HER/Neu-Positive Metastatic Breast Cancer
PRIMARY OBJECTIVES:
I. Determine the response rate in patients with HER2/neu-positive metastatic breast cancer
treated with trastuzumab (Herceptin®), ixabepilone, and carboplatin.
SECONDARY OBJECTIVES:
I. Determine the time to disease progression and time to treatment failure in patients
treated with this regimen.
II. Determine the toxicity of this regimen in these patients. III. Determine the overall
survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
INDUCTION THERAPY: Patients receive trastuzumab (Herceptin®) IV over 30 minutes* on days 1,
8, 15, and 22 and ixabepilone IV over 1 hour and carboplatin IV over 1 hour on days 1, 8,
and 15. Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable
toxicity.
NOTE: *Trastuzumab is given over 90 minutes on day 1 of course 1 (induction therapy) only.
MAINTENANCE THERAPY: Patients receive trastuzumab IV over 90 minutes on day 1. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years from
study entry.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response for HER2+ Patients (Best Objective Response a Patient Has Ever Experienced on Study)
To assess objective response, it is necessary to estimate the overall tumor burden at baseline to which subsequent measurements will be compared. The same method of assessment and the same technique should be used to characterize each lesion at baseline and during follow-up. The best overall response based on RECIST is the best response recorded from registration until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since registration. The best response was determined based on the tumor responses in target and nontarget lesions, with or without new lesions. To be assigned a status of complete or partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 8 weeks.
Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years
No
Stacy L. Moulder, MD, MSCI
Study Chair
M.D. Anderson Cancer Center
United States: Federal Government
NCI-2012-02946
NCT00077376
March 2004
March 2011
Name | Location |
---|---|
Akron City Hospital | Akron, Ohio 44304 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
St. Rita's Medical Center | Lima, Ohio 45801 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Columbus | Columbus, Ohio 43206 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44106 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Tufts - New England Medical Center | Boston, Massachusetts 02111 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown, New Jersey 07962 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
Cancer Institute of New Jersey at Hamilton | Hamilton, New Jersey 08690 |
St. Luke's Hospital Cancer Center | Bethlehem, Pennsylvania 18015 |
Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota 55805 |
Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx, New York 10466 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Siouxland Regional Cancer Center | Sioux City, Iowa 51101-1733 |
Fox Chase Virtua Health Cancer Program - Marlton | Marlton, New Jersey 08053 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grant Riverside Cancer Services | Columbus, Ohio 43215 |
Mount Carmel West Hospital | Columbus, Ohio 43222 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville, Ohio 43081 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
Hematology Oncology Associates - Skokie | Skokie, Illinois 60076 |
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | Camden, New Jersey 08103 |
Memorial Medical Center Cancer Services | Modesto, California 95355 |
Beebe Medical Center | Lewes, Delaware 19958 |
St. Francis Hospital | Wilmington, Delaware 19805 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Swedish Covenant Hospital | Chicago, Illinois 60625 |
Mercy Hospital and Medical Center | Chicago, Illinois 60616 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
Midwest Center for Hematology/Oncology | Joliet, Illinois 60432 |
Kewanee Hospital | Kewanee, Illinois 61443 |
North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville, Illinois 60048 |
McDonough District Hospital | Macomb, Illinois 61455 |
Northwest Medical Specialist, PC | Niles, Illinois 60714 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Midwest Cancer Research Group, Incorporated | Skokie, Illinois 60077 |
Hematology/Oncology of the North Shore at Gross Point Medical Center | Skokie, Illinois 60076 |
St. Margaret's Hospital | Spring Valley, Illinois 61362 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
McFarland Clinic, P. C. | Ames, Iowa 50010 |
St. Luke's Hospital | Cedar Rapids, Iowa 52402 |
Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Capitol Hospital | Des Moines, Iowa 50307 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Burgess Health Center | Onawa, Iowa 51040 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Ochsner Clinic of Baton Rouge | Baton Rouge, Louisiana 708169990 |
Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
Terrebonne General Medical Center | Houma, Louisiana 70360 |
Medical Center of Louisiana - New Orleans | New Orleans, Louisiana 70112 |
Union Hospital Cancer Center at Union Hospital | Elkton MD, Maryland 21921 |
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor, Michigan 48106-0995 |
Green Bay Oncology, Limited - Iron Mountain | Iron Mountain, Michigan 49801 |
Alexandria, Minnesota 56308 | |
Brainerd Medical Center | Brainerd, Minnesota 56401 |
St. Joseph's Medical Center | Brainerd, Minnesota 56401 |
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Chippewa County - Montevideo Hospital | Montevideo, Minnesota 56265 |
Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
Coborn Cancer Center | Saint Cloud, Minnesota 56303 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Park Nicollet Health Services | St. Louis Park, Minnesota 55416 |
Hattiesburg Clinic, P.A. | Hattiesburg, Mississippi 39401 |
Bryan LGH Medical Center West | Lincoln, Nebraska 68502 |
St. Elizabeth Regional Medical Center | Lincoln, Nebraska 68510 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Mountainside Hospital Cancer Center | Montclair, New Jersey 07042 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
Mercy Medical Center | Springfield, Ohio 45504 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Dean Medical Center - Fish Hatchery | Madison, Wisconsin 53715 |
Joliet Oncology Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Oncology Hematology Associates of Central Illinois - Ottawa | Ottawa, Illinois 61350 |
Baton Rouge General Regional Cancer Center | Baton Rouge, Louisiana 70821 |
Miller-Dwan Medical Center | Duluth, Minnesota 55805 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
Saint Francis Cancer Center | Shakopee, Minnesota 55379 |
St. Joseph's Hospital | St Paul, Minnesota 55102 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
University Hospitals Ireland Cancer Center at Mercy Medical Center | Canton, Ohio 44708 |
St. Joseph Medical Center | Reading, Pennsylvania 19604 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Newton-Wellesley Hospital | Newton, Massachusetts 02462 |
Woodwinds Health Campus | Woodbury, Minnesota 55125 |
Shore Memorial Hospital - Somers Point | Somers Point, New Jersey 08244 |
Alexian Brothers Radiation Oncology | Elk Grove Village, Illinois 60007 |
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields | Olympia Fields, Illinois 60461 |
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center | Sioux City, Iowa 51101 |
Commonwealth Hematology-Oncology P. C. - Quincy | Quincy, Massachusetts 02169 |