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Phase II Study of Capecitabine in Combination With Vinorelbine and Trastuzumab for the First- or Second-LineTreatment of HER2+ Metastatic Breast Cancer


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

Thank you

Trial Information

Phase II Study of Capecitabine in Combination With Vinorelbine and Trastuzumab for the First- or Second-LineTreatment of HER2+ Metastatic Breast Cancer


OBJECTIVES:

Primary

- Determine the overall response rate in patients with HER2/neu-overexpressing metastatic
breast cancer treated with first- or second-line therapy comprising capecitabine,
vinorelbine, and trastuzumab (Herceptin^®).

Secondary

- Determine the time to disease progression, duration of response, and overall survival
of patients treated with this regimen.

- Determine the safety profile of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily on days 1-14, vinorelbine IV over 6-10
minutes on days 1 and 8, and trastuzumab (Herceptin^®) IV over 30-90 minutes on day 1.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months for
up to 5 years.

PROJECTED ACCRUAL: A total of 5-47 patients will be accrued for this study within 23 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed invasive breast cancer

- Metastatic disease

- HER2/neu-positive by immunohistochemistry (3+ by HercepTest^™ or equivalent) OR
positive for amplification by fluorescent in situ hybridization

- Testing may be performed in the primary tumor or the metastatic site

- Received prior anthracycline or taxane as adjuvant therapy or for metastatic disease

- Measurable disease

- At least one measurable lesion ≥ 2.0 cm by CT scan or MRI OR ≥ 1.0 cm by spiral
CT scan

- The following are considered non-measurable disease:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- No bone metastases as the only evidence of metastasis

- Previously treated CNS metastases allowed provided disease has been stable for ≥ the
past 3 months

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 18 and over

Sex

- Female or male

Menopausal status

- Not specified

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Hemoglobin ≥ 8.0 g/dL

- Platelet count ≥ 100,000/mm^3

- No known uncontrolled coagulopathy

Hepatic

- Bilirubin ≤ 3.0 times the upper limit of normal (ULN)

- One of the following must be true:

- AST or ALT ≤ 5 times ULN AND alkaline phosphatase normal

- Alkaline phosphatase ≤ 5 times ULN AND AST or ALT normal

- Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

- INR ≤ 1.5 times ULN

Renal

- Calcium ≤ 11.5 mg/dL

- Creatinine ≤ 1.5 times ULN

- Creatinine clearance ≥ 30 mL/min

Cardiovascular

- LVEF ≥ 50% by MUGA or echocardiogram

- No clinically significant (i.e., active) cardiac disease

- No congestive heart failure

- No symptomatic coronary artery disease

- No myocardial infarction within the past 12 months

- No cardiac arrhythmia not controlled with medication

Gastrointestinal

- Able to take oral medication

- No lack of physical integrity of the upper gastrointestinal tract

- No clinically significant malabsorption syndrome

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after study
participation

- No history of allergy or hypersensitivity to study drugs, drug product excipients,
including polysorbate 80, or chemically similar agents

- No prior unanticipated severe reaction to fluoropyrimidine therapy

- No know hypersensitivity to fluorouracil

- No known dihydropyrimidine dehydrogenase deficiency

- No history of uncontrolled seizures or CNS disorders

- No clinically significant psychiatric disability that would preclude giving informed
consent or study compliance

- No other serious uncontrolled infection or disease

- No other malignancy within the past 5 years except cured basal cell skin cancer,
carcinoma in situ of the cervix, or contralateral breast cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Prior adjuvant trastuzumab (Herceptin^®) allowed as adjuvant or first-line therapy
for metastatic disease

- No concurrent immunotherapy

Chemotherapy

- See Disease Characteristics

- No more than 1 prior chemotherapy regimen in the advanced or metastatic
(non-adjuvant) setting

- No prior continuous (≥ 24 hours) fluorouracil infusion

- No prior capecitabine

- No prior oral fluoropyrimidines (e.g., eniluracil and fluorouracil, uracil and
tegafur, S1, or emitefur)

Endocrine therapy

- At least 1 day since prior hormonal therapy

- No concurrent hormonal therapy

Radiotherapy

- More than 4 weeks since prior radiotherapy to the axial skeleton (i.e., skull, spinal
column, sternum, or ribs)

- No concurrent radiotherapy

Surgery

- More than 4 weeks since prior major surgery

- No prior organ allografts requiring immunosuppressive therapy

Other

- More than 4 weeks since prior investigational drugs

- No concurrent sorivudine or its chemically related analogues (e.g., brivudine)

- No concurrent allopurinol, metronidazole, or cimetidine

- No other concurrent cytotoxic agents

- No other concurrent investigational drugs

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate as measured by RECIST criteria

Safety Issue:

No

Principal Investigator

Winston Tan, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000390344

NCT ID:

NCT00093808

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • male breast cancer
  • Breast Neoplasms

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Hurley Medical CenterFlint, Michigan  48503
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
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
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
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
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
MeritCare BemidjiBemidji, Minnesota  56601
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - DuluthDuluth, Minnesota  55805-1983
CCOP - DuluthDuluth, Minnesota  55805
Miller - Dwan Medical CenterDuluth, 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
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's HospitalSt Paul, Minnesota  55102
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health CampusWoodbury, Minnesota  55125
MeritCare BroadwayFargo, North Dakota  58122
CCOP - MeritCare HospitalFargo, North Dakota  58122
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Rapid City Regional HospitalRapid City, South Dakota  57709
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
Hinsdale, Illinois  60521
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
St. Vincent Mercy Medical CenterToledo, Ohio  43608
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
McCreery Cancer Center at Ottumwa RegionalOttumwa, Iowa  52501
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Bettendorf, Iowa  52722
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
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Community Cancer Center of MonroeMonroe, Michigan  48162
Alexandria, Minnesota  56308
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Bismarck Cancer CenterBismarck, North Dakota  58501
Wood County Oncology CenterBowling Green, Ohio  43402
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Firelands Regional Medical CenterSandusky, Ohio  44870
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Fulton County Health CenterWauseon, Ohio  43567
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Altru Cancer Center at Altru HospitalGrand Forks, North Dakota  58201
Allegheny Cancer Center at Allegheny General HospitalPittsburgh, Pennsylvania  15212
McFarland Clinic, PCAmes, Iowa  50010
Foote Memorial HospitalJackson, Michigan  49201
Haematology-Oncology Associates of Ohio and Michigan, PCLambertville, Michigan  48144
St. Mary Mercy HospitalLivonia, Michigan  48154
Mercy Memorial Hospital - MonroeMonroe, Michigan  48162
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Flower Hospital Cancer CenterSylvania, Ohio  43560
Fredericksburg Oncology, IncorporatedFredericksburg, Virginia  22401
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Galesburg Clinic, PCGalesburg, Illinois  61401
Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMoline, Illinois  61265
Franciscan Skemp Healthcare - La Crosse CampusLa Crosse, Wisconsin  54601
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502