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A Phase II Trial Of Trastuzumab Plus Weekly Ixabepilone (BMS-247550) And Carboplatin In Patients With HER/Neu-Positive Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

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.

Inclusion Criteria


Inclusion criteria:

- Histologically confirmed adenocarcinoma of the breast

- Metastatic disease

- HER2/neu-positive (3+) disease by immunohistochemistry or fluorescent in situ
hybridization

- At least 1 objectively measurable disease parameter

- No brain metastases as the only site of measurable disease

- Previously irradiated tumors are not considered measurable disease, except for
recurrent disease located in an area of prior adjuvant irradiation (e.g., axilla
or chest wall)

- Age >= 18

- ECOG performance status of 0-1

- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- AST and ALT ≤ 1.5 times upper limit of normal (ULN) (2.0 times ULN for patients with
liver involvement by tumor)

- Creatinine ≤ 1.5 mg/dL

- LVEF within lower limit of normal by MUGA or echocardiogram

- Negative pregnancy test

- Fertile patients must use effective nonhormonal contraception

- At least 1 week since prior hormonal therapy

- At least 2 weeks since prior radiotherapy

Exclusion criteria:

- Untreated brain metastases

- Previously treated brain metastases that have responded to prior radiotherapy
and/or surgery are allowed

- New York Heart Association class III or IV heart disease

- Pregnant or nursing

- Prior severe (grade 3 or 4) hypersensitivity reaction to drugs formulated in
polyoxyethylated castor oil (Cremophor EL)

- Peripheral neuropathy

- Other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- Prior trastuzumab (Herceptin®) for metastatic disease

- Concurrent pegfilgrastim

- Prior ixabepilone for metastatic disease

- Prior carboplatin or other chemotherapy for metastatic disease

- Prior cumulative doxorubicin dose > 360 mg/m^2

- Prior cumulative epirubicin dose > 640 mg/m^2

- Concurrent hormonal therapy

- Concurrent radiotherapy, including radiotherapy for brain metastases

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response for HER2+ Patients (Best Objective Response a Patient Has Ever Experienced on Study)

Outcome Description:

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.

Outcome Time Frame:

Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years

Safety Issue:

No

Principal Investigator

Stacy L. Moulder, MD, MSCI

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

NCI-2012-02946

NCT ID:

NCT00077376

Start Date:

March 2004

Completion Date:

March 2011

Related Keywords:

  • Breast Cancer
  • Trastuzumab
  • Ixabepilone
  • Carboplatin
  • HER2/Neu-Positive
  • Metastatic Breast Cancer
  • Breast Neoplasms

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