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Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer

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Trial Identification

Brief Title: Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer

Official Title: 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)

Study ID: NCT00003352

Conditions

Breast Cancer

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of doxorubicin, cyclophosphamide, and docetaxel in treating women with stage IIIB or stage IV breast cancer.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Baptist Medical Center - Birmingham, Birmingham, Alabama, United States

Huntsville Hospital System, Huntsville, Alabama, United States

MBCCOP - University of South Alabama, Mobile, Alabama, United States

CCOP - Greater Phoenix, Phoenix, Arizona, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Beckman Research Institute, City of Hope, Duarte, California, United States

Scripps Clinic and Research Foundation - La Jolla, La Jolla, California, United States

University of California San Diego Cancer Center, La Jolla, California, United States

Loma Linda University Medical Center, Loma Linda, California, United States

Saint Mary Medical Center - Long Beach, Long Beach, California, United States

CCOP - Bay Area Tumor Institute, Oakland, California, United States

Naval Medical Center - Oakland, Oakland, California, United States

Sutter Cancer Center, Sacramento, California, United States

Veterans Affairs Satellite Clinic - Sacramento, Sacramento, California, United States

Naval Medical Center - San Diego, San Diego, California, United States

Veterans Affairs Medical Center - San Francisco, San Francisco, California, United States

CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, United States

Kaiser Permanente Medical Center - Vallejo, Vallejo, California, United States

CCOP - Colorado Cancer Research Program, Inc., Denver, Colorado, United States

University of Colorado Cancer Center, Denver, Colorado, United States

Hartford Hospital, Hartford, Connecticut, United States

CCOP - Christiana Care Health Services, Wilmington, Delaware, United States

Baptist Regional Cancer Institute - Jacksonville, Jacksonville, Florida, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States

Sylvester Cancer Center, University of Miami, Miami, Florida, United States

Ocala Oncology Center, Ocala, Florida, United States

MD Anderson Cancer Center Orlando, Orlando, Florida, United States

Sarasota Memorial Hospital, Sarasota, Florida, United States

Winship Cancer Center, Atlanta, Georgia, United States

CCOP - Atlanta Regional, Atlanta, Georgia, United States

Medical College of Georgia Comprehensive Cancer Center, Augusta, Georgia, United States

Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, United States

Cancer Research Center of Hawaii, Honolulu, Hawaii, United States

Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States

Illinois Masonic Medical Center, Chicago, Illinois, United States

CCOP - Evanston, Evanston, Illinois, United States

Highland Park Hospital, Highland Park, Illinois, United States

West Suburban Hospital Medical Center, Oak Park, Illinois, United States

Rockford Clinic, Rockford, Illinois, United States

CCOP - Central Illinois, Springfield, Illinois, United States

CCOP - Carle Cancer Center, Urbana, Illinois, United States

Methodist Cancer Center - Indianapolis, Indianapolis, Indiana, United States

Community Hospitals of Indianapolis - Regional Cancer Center, Indianapolis, Indiana, United States

Memorial Hospital of South Bend, South Bend, Indiana, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

University of Kansas Medical Center, Kansas City, Kansas, United States

CCOP - Wichita, Wichita, Kansas, United States

Veterans Affairs Medical Center - Wichita, Wichita, Kansas, United States

Lucille Parker Markey Cancer Center, University of Kentucky, Lexington, Kentucky, United States

Norton Healthcare System, Louisville, Kentucky, United States

Baptist Hospital East - Louisville, Louisville, Kentucky, United States

Louisiana State University Medical Center - New Orleans, New Orleans, Louisiana, United States

Tulane University School of Medicine, New Orleans, Louisiana, United States

Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, United States

CCOP - Ochsner, New Orleans, Louisiana, United States

Eastern Maine Medical Center, Bangor, Maine, United States

Franklin Square Hospital Center, Baltimore, Maryland, United States

National Naval Medical Center, Bethesda, Maryland, United States

Regional Cancer Therapy Center - Frederick, Frederick, Maryland, United States

New England Medical Center Hospital, Boston, Massachusetts, United States

Boston Medical Center, Boston, Massachusetts, United States

Lahey Clinic - Burlington, Burlington, Massachusetts, United States

Berkshire Medical Center, Pittsfield, Massachusetts, United States

Baystate Medical Center, Springfield, Massachusetts, United States

CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States

Michigan State University, East Lansing, Michigan, United States

CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, United States

CCOP - Kalamazoo, Kalamazoo, Michigan, United States

Providence Hospital - Southfield, Southfield, Michigan, United States

CCOP - Duluth, Duluth, Minnesota, United States

Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States

Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi, United States

Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States

CCOP - Kansas City, Kansas City, Missouri, United States

St. Louis University School of Medicine, Saint Louis, Missouri, United States

CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, United States

CCOP - Montana Cancer Consortium, Billings, Montana, United States

Methodist Cancer Center - Omaha, Omaha, Nebraska, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States

Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States

CCOP - Northern New Jersey, Hackensack, New Jersey, United States

Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States

Newark Beth Israel Medical Center, Newark, New Jersey, United States

University of New Mexico Cancer Research & Treatment Center, Albuquerque, New Mexico, United States

Albany Regional Cancer Center, Albany, New York, United States

State University of New York Health Science Center at Brooklyn, Brooklyn, New York, United States

CCOP - North Shore University Hospital, Manhasset, New York, United States

Mount Sinai Medical Center, NY, New York, New York, United States

Genesee Hospital - Rochester, Rochester, New York, United States

Staten Island University Hospital, Staten Island, New York, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States

East Carolina University School of Medicine, Greenville, North Carolina, United States

CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States

Veterans Affairs Medical Center - Fargo, Fargo, North Dakota, United States

CCOP - Merit Care Hospital, Fargo, North Dakota, United States

Akron City Hospital, Akron, Ohio, United States

Barrett Cancer Center, The University Hospital, Cincinnati, Ohio, United States

Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, United States

Jewish Hospital of Cincinnati, Inc., Cincinnati, Ohio, United States

Meridia South Pointe Hospital, Cleveland, Ohio, United States

Mount Sinai Medical Center - Cleveland, Cleveland, Ohio, United States

CCOP - Columbus, Columbus, Ohio, United States

Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States

Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States

CCOP - Dayton, Kettering, Ohio, United States

CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, United States

CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center, Tulsa, Oklahoma, United States

Oregon Cancer Center at Oregon Health Sciences University, Portland, Oregon, United States

CCOP - Columbia River Program, Portland, Oregon, United States

Lehigh Valley Hospital, Allentown, Pennsylvania, United States

St. Luke's Network - Bethlehem, Bethlehem, Pennsylvania, United States

Penn State Geisinger Medical Center, Danville, Pennsylvania, United States

Albert Einstein Cancer Center, Philadelphia, Pennsylvania, United States

Allegheny General Hospital, Pittsburgh, Pennsylvania, United States

University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States

Veterans Affairs Medical Center - Pittsburgh, Pittsburgh, Pennsylvania, United States

Reading Hospital and Medical Center, Reading, Pennsylvania, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania, United States

Rhode Island Hospital, Providence, Rhode Island, United States

Kent County Memorial Hospital - Rhode Island, Warwick, Rhode Island, United States

Medical University of South Carolina, Charleston, South Carolina, United States

CCOP - Greenville, Greenville, South Carolina, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States

Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, United States

CCOP - Baptist Cancer Institute, Memphis, Tennessee, United States

Medical Group of Texas, Dallas, Texas, United States

Kelsey Seybold Clinic, Houston, Texas, United States

Wilford Hall - 59th Medical Wing, Lackland Air Force Base, Texas, United States

MBCCOP - South Texas Pediatric, San Antonio, Texas, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

University of Texas Health Center at Tyler, Tyler, Texas, United States

Utah Valley Regional Medical Center - Provo, Provo, Utah, United States

Virginia Oncology Associates, Newport News, Virginia, United States

Eastern Virginia Medical School, Norfolk, Virginia, United States

Veterans Affairs Medical Center - Richmond, Richmond, Virginia, United States

Massey Cancer Center, Richmond, Virginia, United States

MBCCOP - Massey Cancer Center, Richmond, Virginia, United States

Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke, Virginia, United States

Veterans Affairs Medical Center - Salem, Salem, Virginia, United States

CCOP - Virginia Mason Research Center, Seattle, Washington, United States

Puget Sound Oncology Consortium, Seattle, Washington, United States

CCOP - Northwest, Tacoma, Washington, United States

Camden-Clark Memorial Hospital, Parkersburg, West Virginia, United States

CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin, United States

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada

Cross Cancer Institute, Edmonton, Alberta, Canada

British Columbia Cancer Agency, Vancouver, British Columbia, Canada

Manitoba Cancer Treatment and Research Foundation, Winnipeg, Manitoba, Canada

Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada

St. Michael's Hospital - Toronto, Toronto, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada

Royal Victoria Hospital - Montreal, Montreal, Quebec, Canada

Montreal General Hospital, Montreal, Quebec, Canada

Jewish General Hospital - Montreal, Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec, Quebec City, Quebec, Canada

Hopital Laval, Ste-Foy, Quebec, Canada

MBCCOP - San Juan, San Juan, , Puerto Rico

Veterans Affairs Medical Center - San Juan, San Juan, , Puerto Rico

Contact Details

Name: Norman Wolmark, MD

Affiliation: NSABP Foundation Inc

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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