Know Cancer

or
forgot password

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 HospitalAkron, Ohio  44304
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Bergan Mercy Medical CenterOmaha, Nebraska  68124
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
CCOP - DuluthDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
St. Rita's Medical CenterLima, Ohio  45801
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
CCOP - OchsnerNew Orleans, Louisiana  70121
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
CCOP - Scott and White HospitalTemple, Texas  76508
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Tufts - New England Medical CenterBoston, Massachusetts  02111
Overlook HospitalSummit, New Jersey  07902-0220
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
St. Luke's Hospital Cancer CenterBethlehem, Pennsylvania  18015
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Fox Chase Virtua Health Cancer Program - MarltonMarlton, New Jersey  08053
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grant Riverside Cancer ServicesColumbus, Ohio  43215
Mount Carmel West HospitalColumbus, Ohio  43222
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Mount Carmel Cancer Services at Mount Carmel St. Ann's HospitalWesterville, Ohio  43081
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Elkhart General HospitalElkhart, Indiana  46515
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
Cancer Institute of New Jersey at the Cooper University Hospital - VoorheesCamden, New Jersey  08103
Memorial Medical Center Cancer ServicesModesto, California  95355
Beebe Medical CenterLewes, Delaware  19958
St. Francis HospitalWilmington, Delaware  19805
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Swedish Covenant HospitalChicago, Illinois  60625
Mercy Hospital and Medical CenterChicago, Illinois  60616
Hematology and Oncology AssociatesChicago, Illinois  60611
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Ingalls Cancer Care Center at Ingalls Memorial HospitalHarvey, Illinois  60426
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Midwest Center for Hematology/OncologyJoliet, Illinois  60432
Kewanee HospitalKewanee, Illinois  61443
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
McDonough District HospitalMacomb, Illinois  61455
Northwest Medical Specialist, PCNiles, Illinois  60714
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
Midwest Cancer Research Group, IncorporatedSkokie, Illinois  60077
Hematology/Oncology of the North Shore at Gross Point Medical CenterSkokie, Illinois  60076
St. Margaret's HospitalSpring Valley, Illinois  61362
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
McFarland Clinic, P. C.Ames, Iowa  50010
St. Luke's HospitalCedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Burgess Health CenterOnawa, Iowa  51040
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Ochsner Clinic of Baton RougeBaton Rouge, Louisiana  708169990
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Terrebonne General Medical CenterHouma, Louisiana  70360
Medical Center of Louisiana - New OrleansNew Orleans, Louisiana  70112
Union Hospital Cancer Center at Union HospitalElkton MD, Maryland  21921
St. Joseph Mercy Cancer Center at St. Joseph Mercy HospitalAnn Arbor, Michigan  48106-0995
Green Bay Oncology, Limited - Iron MountainIron Mountain, Michigan  49801
Alexandria, Minnesota  56308
Brainerd Medical CenterBrainerd, Minnesota  56401
St. Joseph's Medical CenterBrainerd, Minnesota  56401
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Chippewa County - Montevideo HospitalMontevideo, Minnesota  56265
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Hattiesburg Clinic, P.A.Hattiesburg, Mississippi  39401
Bryan LGH Medical Center WestLincoln, Nebraska  68502
St. Elizabeth Regional Medical CenterLincoln, Nebraska  68510
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Mountainside Hospital Cancer CenterMontclair, New Jersey  07042
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
Mercy Medical CenterSpringfield, Ohio  45504
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Green Bay Oncology, Limited at St. Vincent HospitalGreen Bay, Wisconsin  54301-3526
Dean Medical Center - Fish HatcheryMadison, Wisconsin  53715
Joliet Oncology Hematology Associates, Limited - WestJoliet, Illinois  60435
Oncology Hematology Associates of Central Illinois - OttawaOttawa, Illinois  61350
Baton Rouge General Regional Cancer CenterBaton Rouge, Louisiana  70821
Miller-Dwan Medical CenterDuluth, Minnesota  55805
Geisinger Medical GroupState College, Pennsylvania  16801
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Saint Francis Cancer CenterShakopee, Minnesota  55379
St. Joseph's HospitalSt Paul, Minnesota  55102
Cancer Resource Center - LincolnLincoln, Nebraska  68510
University Hospitals Ireland Cancer Center at Mercy Medical CenterCanton, Ohio  44708
St. Joseph Medical CenterReading, Pennsylvania  19604
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Newton-Wellesley HospitalNewton, Massachusetts  02462
Woodwinds Health CampusWoodbury, Minnesota  55125
Shore Memorial Hospital - Somers PointSomers Point, New Jersey  08244
Alexian Brothers Radiation OncologyElk Grove Village, Illinois  60007
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia FieldsOlympia Fields, Illinois  60461
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer CenterSioux City, Iowa  51101
Commonwealth Hematology-Oncology P. C. - QuincyQuincy, Massachusetts  02169