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A Phase II Study in Patients With Metastatic or Locally Advanced Breast Cancer to Evaluate the Worth of the Combination of Adriamycin (Doxorubicin), Taxotere (Docetaxel), and Cyclophosphamide (ATC)


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

Thank you

Trial Information

A Phase II Study in Patients With Metastatic or Locally Advanced Breast Cancer to Evaluate the Worth of the Combination of Adriamycin (Doxorubicin), Taxotere (Docetaxel), and Cyclophosphamide (ATC)


OBJECTIVES: I. Determine the overall response rate to doxorubicin, docetaxel, and
cyclophosphamide (ATC) in women with metastatic or locally advanced breast cancer. II.
Determine survival, time to first response, time to progression, and duration of response in
these patients. III. Evaluate the feasibility of administering ATC for at least 4 courses.
IV. Evaluate the toxicity profile of ATC and its effect on cardiac function.

OUTLINE: Patients receive intravenous doxorubicin over 15 minutes on day 0, followed by
intravenous cyclophosphamide over 30 minutes. An hour after the end of the doxorubicin
infusion, intravenous docetaxel is administered over 1 hour. Patients receive courses every
21 days until disease progression or unacceptable toxic effects are observed. When the
maximum dose of doxorubicin is reached, treatment continues with docetaxel and
cyclophosphamide. Patients with locally advanced breast cancer receive chemotherapy for at
least 2 courses after documented response. Patients are followed every 6 weeks.

PROJECTED ACCRUAL: Approximately 89 patients will be accrued to this study within 14 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven metastatic (stage IV) or locally advanced
(stage IIIB) adenocarcinoma of the breast. Bidimensionally measurable disease. No active
central nervous system (CNS) metastases. Brain metastases must be controlled for at least
3 months and have other sites of measurable disease. No carcinomatous meningitis. No
lymphangitic lung metastases as the only site of metastatic disease. Hormone receptor
status: Any estrogen or progesterone receptor status.

PATIENT CHARACTERISTICS: Age: 18 and over. Sex: Female. Menopausal status: Not specified.
Performance status: Eastern Cooperative Oncology Group (ECOG) score range 0-2. Life
expectancy: At least 6 months. Hematopoietic: Absolute neutrophil count at least
2,000/mm3. Platelet count at least 100,000/mm3. Hepatic: serum glutamic oxaloacetic
transaminase (SGOT) and/or serum glutamic pyruvic transaminase (SGPT) no greater than 2.5
times upper limit of normal (ULN). Alkaline phosphatase no greater than 5 times ULN.
Bilirubin no greater than ULN. No SGOT and/or SGPT greater than 1.5 times ULN if
concomitant with alkaline phosphatase greater than 2.5 times ULN. Renal: Calcium no
greater than 1.2 times ULN. Creatinine no greater than 1.5 times ULN. Cardiovascular:left
ventricular ejection fraction (LVEF) at least institutional lower limit of normal on
multiple gated acquisition scan (MUGA) or echocardiogram. No myocardial infarction within
6 months. No angina pectoris requiring antianginal medication. No history of congestive
heart failure. No cardiac arrhythmias requiring medication. No vascular disease with
documented cardiac function compromise No uncontrolled hypertension (diastolic greater
than 100 mm Hg). Other: Not pregnant or nursing. Fertile patients must use effective
barrier contraception. No diabetics with fasting blood sugar greater than 200 mg/dL. No
peripheral neuropathy greater than grade 1. No psychosis or addictive disorders. No known
hypersensitivity to E. coli-derived drugs.

PRIOR CONCURRENT THERAPY: Chemotherapy: No prior chemotherapy for metastatic breast cancer
or non-breast cancer. At least 12 months since nontaxane containing adjuvant chemotherapy
for primary tumor (in patients with metastatic disease). Prior adjuvant chemotherapy with
anthracycline containing regimens allowed (provided total doxorubicin dose did not exceed
240 mg/m2). Endocrine therapy: At least 4 weeks since adjuvant hormone or hormone therapy
for metastatic disease (at least 2 weeks for rapidly progressive disease). No concurrent
hormonal birth control. Radiotherapy: At least 4 weeks since prior radiotherapy. Prior
breast radiotherapy following lumpectomy allowed. No radiotherapy to greater than 30% of
bone marrow. No prior left chest wall radiotherapy with anthracycline containing adjuvant
chemotherapy. Surgery: Not specified.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Best over-all tumor response that occurs during 6 cycles of chemotherapy

Outcome Time Frame:

18 weeks

Safety Issue:

No

Principal Investigator

Norman Wolmark, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NSABP Foundation, Inc.

Authority:

United States: Federal Government

Study ID:

NSABP BP-58

NCT ID:

NCT00003352

Start Date:

June 1998

Completion Date:

December 2002

Related Keywords:

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

Name

Location

Akron City HospitalAkron, Ohio  44304
National Naval Medical CenterBethesda, Maryland  20889
University of Colorado Cancer CenterDenver, Colorado  80262
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
CCOP - WichitaWichita, Kansas  67214-3882
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
Rhode Island HospitalProvidence, Rhode Island  02903
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Baptist Cancer InstituteMemphis, Tennessee  38117
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
CCOP - Colorado Cancer Research Program, Inc.Denver, Colorado  80209-5031
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
New England Medical Center HospitalBoston, Massachusetts  02111
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
CCOP - DuluthDuluth, Minnesota  55805
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Medical College of WisconsinMilwaukee, Wisconsin  53226
Huntsville Hospital SystemHuntsville, Alabama  35801
MBCCOP - University of South AlabamaMobile, Alabama  36688
Loma Linda University Medical CenterLoma Linda, California  92354
Beckman Research Institute, City of HopeLos Angeles, California  91010
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
CCOP - Central IllinoisSpringfield, Illinois  62526
Community Hospitals of Indianapolis - Regional Cancer CenterIndianapolis, Indiana  46219
Memorial Hospital of South BendSouth Bend, Indiana  46601
Tulane University School of MedicineNew Orleans, Louisiana  70112
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Methodist Cancer Center - OmahaOmaha, Nebraska  68114
Newark Beth Israel Medical CenterNewark, New Jersey  07112
Genesee Hospital - RochesterRochester, New York  14607
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
Lehigh Valley HospitalAllentown, Pennsylvania  18103
Penn State Geisinger Medical CenterDanville, Pennsylvania  17822-2001
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - GreenvilleGreenville, South Carolina  29615
Wilford Hall - 59th Medical WingLackland Air Force Base, Texas  78236-5300
Massey Cancer CenterRichmond, Virginia  23298-0037
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
Baptist Regional Cancer Institute - JacksonvilleJacksonville, Florida  32207
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
Boston Medical CenterBoston, Massachusetts  02118
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
CCOP - NorthwestTacoma, Washington  98405-0986
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
Puget Sound Oncology ConsortiumSeattle, Washington  98109
Saint Mary Medical Center - Long BeachLong Beach, California  90813-0887
Naval Medical Center - OaklandOakland, California  94627-5000
Sutter Cancer CenterSacramento, California  95816
Veterans Affairs Satellite Clinic - SacramentoSacramento, California  95820
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
Hartford HospitalHartford, Connecticut  06102-5037
Sarasota Memorial HospitalSarasota, Florida  34239
Medical College of Georgia Comprehensive Cancer CenterAugusta, Georgia  30912-4000
Illinois Masonic Medical CenterChicago, Illinois  60657
West Suburban Hospital Medical CenterOak Park, Illinois  60302
Rockford ClinicRockford, Illinois  61103
Lucille Parker Markey Cancer Center, University of KentuckyLexington, Kentucky  40536-0093
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
Norton Healthcare SystemLouisville, Kentucky  40202-5070
Louisiana State University Medical Center - New OrleansNew Orleans, Louisiana  70112
Eastern Maine Medical CenterBangor, Maine  04401
Franklin Square Hospital CenterBaltimore, Maryland  21237
Regional Cancer Therapy Center - FrederickFrederick, Maryland  21701
Lahey Clinic - BurlingtonBurlington, Massachusetts  01805
Berkshire Medical CenterPittsfield, Massachusetts  01201
Baystate Medical CenterSpringfield, Massachusetts  01199
Michigan State UniversityEast Lansing, Michigan  48824
St. Louis University School of MedicineSaint Louis, Missouri  63104
University of New Mexico Cancer Research & Treatment CenterAlbuquerque, New Mexico  87131
Albany Regional Cancer CenterAlbany, New York  12208
Staten Island University HospitalStaten Island, New York  10305
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - FargoFargo, North Dakota  58102
Jewish Hospital of Cincinnati, Inc.Cincinnati, Ohio  45236
St. Luke's Network - BethlehemBethlehem, Pennsylvania  18015
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
Veterans Affairs Medical Center - PittsburghPittsburgh, Pennsylvania  15240
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Medical Group of TexasDallas, Texas  75243
Kelsey Seybold ClinicHouston, Texas  77025
University of Texas Health Center at TylerTyler, Texas  75708
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Eastern Virginia Medical SchoolNorfolk, Virginia  23507
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
Oncology and Hematology Associates of Southwest Virginia, Inc.Roanoke, Virginia  24014
Camden-Clark Memorial HospitalParkersburg, West Virginia  26102
MBCCOP - South Texas PediatricSan Antonio, Texas  78284-7810
Kent County Memorial Hospital - Rhode IslandWarwick, Rhode Island  02886
Virginia Oncology AssociatesNewport News, Virginia  23606
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
Baptist Medical Center - BirminghamBirmingham, Alabama  35213
Scripps Clinic and Research Foundation - La JollaLa Jolla, California  92037
Ocala Oncology CenterOcala, Florida  34474
Winship Cancer CenterAtlanta, Georgia  30322
Highland Park HospitalHighland Park, Illinois  60035-2497
Methodist Cancer Center - IndianapolisIndianapolis, Indiana  46206-1367
Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Good Samaritan Hospital - CincinnatiCincinnati, Ohio  45220
Mount Sinai Medical Center - ClevelandCleveland, Ohio  44122
Meridia South Pointe HospitalCleveland, Ohio  44122
Veterans Affairs Medical Center - SalemSalem, Virginia  24153