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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Best over-all tumor response that occurs during 6 cycles of chemotherapy
18 weeks
No
Norman Wolmark, MD
Principal Investigator
NSABP Foundation, Inc.
United States: Federal Government
NSABP BP-58
NCT00003352
June 1998
December 2002
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 |