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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 Hospital Akron, Ohio  44304
National Naval Medical Center Bethesda, Maryland  20889
University of Colorado Cancer Center Denver, Colorado  80262
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Medical University of South Carolina Charleston, South Carolina  29425-0721
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Sylvester Cancer Center, University of Miami Miami, Florida  33136
CCOP - Wichita Wichita, Kansas  67214-3882
East Carolina University School of Medicine Greenville, North Carolina  27858-4354
Rhode Island Hospital Providence, Rhode Island  02903
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Baptist Cancer Institute Memphis, Tennessee  38117
University of California San Diego Cancer Center La Jolla, California  92093-0658
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
CCOP - North Shore University Hospital Manhasset, New York  11030
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New 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 Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
New England Medical Center Hospital Boston, Massachusetts  02111
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
CCOP - Northern New Jersey Hackensack, New Jersey  07601
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
CCOP - Duluth Duluth, Minnesota  55805
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
MD Anderson Cancer Center Orlando Orlando, Florida  32806
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Merit Care Hospital Fargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Huntsville Hospital System Huntsville, Alabama  35801
MBCCOP - University of South Alabama Mobile, Alabama  36688
Loma Linda University Medical Center Loma Linda, California  92354
Beckman Research Institute, City of Hope Los Angeles, California  91010
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
CCOP - Central Illinois Springfield, Illinois  62526
Community Hospitals of Indianapolis - Regional Cancer Center Indianapolis, Indiana  46219
Memorial Hospital of South Bend South Bend, Indiana  46601
Tulane University School of Medicine New Orleans, Louisiana  70112
CCOP - Montana Cancer Consortium Billings, Montana  59101
Methodist Cancer Center - Omaha Omaha, Nebraska  68114
Newark Beth Israel Medical Center Newark, New Jersey  07112
Genesee Hospital - Rochester Rochester, New York  14607
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Program Portland, Oregon  97213
Lehigh Valley Hospital Allentown, Pennsylvania  18103
Penn State Geisinger Medical Center Danville, Pennsylvania  17822-2001
Albert Einstein Cancer Center Philadelphia, Pennsylvania  19141
Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
CCOP - Greenville Greenville, South Carolina  29615
Wilford Hall - 59th Medical Wing Lackland Air Force Base, Texas  78236-5300
Massey Cancer Center Richmond, Virginia  23298-0037
CCOP - Evanston Evanston, Illinois  60201
CCOP - Marshfield Medical Research and Education Foundation Marshfield, Wisconsin  54449
Baptist Regional Cancer Institute - Jacksonville Jacksonville, Florida  32207
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
Boston Medical Center Boston, Massachusetts  02118
Providence Hospital - Southfield Southfield, Michigan  48075-9975
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
CCOP - Virginia Mason Research Center Seattle, Washington  98101
CCOP - Northwest Tacoma, Washington  98405-0986
Veterans Affairs Medical Center - New Orleans New Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences University Portland, Oregon  97201-3098
Puget Sound Oncology Consortium Seattle, Washington  98109
Saint Mary Medical Center - Long Beach Long Beach, California  90813-0887
Naval Medical Center - Oakland Oakland, California  94627-5000
Sutter Cancer Center Sacramento, California  95816
Veterans Affairs Satellite Clinic - Sacramento Sacramento, California  95820
Naval Medical Center - San Diego San Diego, California  92134-3202
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
Kaiser Permanente Medical Center - Vallejo Vallejo, California  94589
Hartford Hospital Hartford, Connecticut  06102-5037
Sarasota Memorial Hospital Sarasota, Florida  34239
Medical College of Georgia Comprehensive Cancer Center Augusta, Georgia  30912-4000
Illinois Masonic Medical Center Chicago, Illinois  60657
West Suburban Hospital Medical Center Oak Park, Illinois  60302
Rockford Clinic Rockford, Illinois  61103
Lucille Parker Markey Cancer Center, University of Kentucky Lexington, Kentucky  40536-0093
Baptist Hospital East - Louisville Louisville, Kentucky  40207
Norton Healthcare System Louisville, Kentucky  40202-5070
Louisiana State University Medical Center - New Orleans New Orleans, Louisiana  70112
Eastern Maine Medical Center Bangor, Maine  04401
Franklin Square Hospital Center Baltimore, Maryland  21237
Regional Cancer Therapy Center - Frederick Frederick, Maryland  21701
Lahey Clinic - Burlington Burlington, Massachusetts  01805
Berkshire Medical Center Pittsfield, Massachusetts  01201
Baystate Medical Center Springfield, Massachusetts  01199
Michigan State University East Lansing, Michigan  48824
St. Louis University School of Medicine Saint Louis, Missouri  63104
University of New Mexico Cancer Research & Treatment Center Albuquerque, New Mexico  87131
Albany Regional Cancer Center Albany, New York  12208
Staten Island University Hospital Staten Island, New York  10305
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Fargo Fargo, North Dakota  58102
Jewish Hospital of Cincinnati, Inc. Cincinnati, Ohio  45236
St. Luke's Network - Bethlehem Bethlehem, Pennsylvania  18015
Allegheny General Hospital Pittsburgh, Pennsylvania  15212-4772
Veterans Affairs Medical Center - Pittsburgh Pittsburgh, Pennsylvania  15240
Veterans Affairs Medical Center - Memphis Memphis, Tennessee  38104
Medical Group of Texas Dallas, Texas  75243
Kelsey Seybold Clinic Houston, Texas  77025
University of Texas Health Center at Tyler Tyler, Texas  75708
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
Eastern Virginia Medical School Norfolk, Virginia  23507
Veterans Affairs Medical Center - Richmond Richmond, Virginia  23249
Oncology and Hematology Associates of Southwest Virginia, Inc. Roanoke, Virginia  24014
Camden-Clark Memorial Hospital Parkersburg, West Virginia  26102
MBCCOP - South Texas Pediatric San Antonio, Texas  78284-7810
Kent County Memorial Hospital - Rhode Island Warwick, Rhode Island  02886
Virginia Oncology Associates Newport News, Virginia  23606
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center Tulsa, Oklahoma  74136
Baptist Medical Center - Birmingham Birmingham, Alabama  35213
Scripps Clinic and Research Foundation - La Jolla La Jolla, California  92037
Ocala Oncology Center Ocala, Florida  34474
Winship Cancer Center Atlanta, Georgia  30322
Highland Park Hospital Highland Park, Illinois  60035-2497
Methodist Cancer Center - Indianapolis Indianapolis, Indiana  46206-1367
Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio  45220
Mount Sinai Medical Center - Cleveland Cleveland, Ohio  44122
Meridia South Pointe Hospital Cleveland, Ohio  44122
Veterans Affairs Medical Center - Salem Salem, Virginia  24153