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

Condition(s) targeted: Breast Cancer

Intervention: cyclophosphamide (Drug); docetaxel (Drug); doxorubicin hydrochloride (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Surgical Adjuvant Breast and Bowel Project (NSABP)

Official(s) and/or principal investigator(s):
Terry Mamounas, MD, MPH, FACS, Study Chair, Affiliation: Aultman Cancer Center at Aultman Hospital

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.

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 design: Treatment

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

DISEASE CHARACTERISTICS: Histologically proven metastatic (stage IV) or locally advanced (stage IIIB) adenocarcinoma of the breast Bidimensionally measurable disease No active 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: ECOG 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: SGOT and/or 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: LVEF at least institutional lower limit of normal on MUGA scan 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: Biologic therapy: Not specified 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

MBCCOP - San Juan, San Juan 00927-5800, Puerto Rico

Veterans Affairs Medical Center - San Juan, San Juan 00927-5800, Puerto Rico

Baptist Medical Center - Birmingham, Birmingham, Alabama 35213, United States

Huntsville Hospital System, Huntsville, Alabama 35801, United States

MBCCOP - University of South Alabama, Mobile, Alabama 36688, United States

Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada

Tom Baker Cancer Center - Calgary, Calgary, Alberta T2N 4N2, Canada

CCOP - Greater Phoenix, Phoenix, Arizona 85006-2726, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

British Columbia Cancer Agency, Vancouver, British Columbia V5Z 4E6, Canada

Beckman Research Institute, City of Hope, Duarte, California 91010, United States

CCOP - Bay Area Tumor Institute, Oakland, California 94609-3305, United States

CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California 95403, United States

Kaiser Permanente Medical Center - Vallejo, Vallejo, California 94589, United States

Loma Linda University Medical Center, Loma Linda, California 92354, United States

Naval Medical Center - Oakland, Oakland, California 94627-5000, United States

Naval Medical Center - San Diego, San Diego, California 92134-3202, United States

Saint Mary Medical Center - Long Beach, Long Beach, California 90813-0887, United States

Scripps Clinic and Research Foundation - La Jolla, La Jolla, California 92037, United States

Sutter Cancer Center, Sacramento, California 95816, United States

University of California San Diego Cancer Center, La Jolla, California 92093-0658, United States

Veterans Affairs Medical Center - San Francisco, San Francisco, California 94121, United States

Veterans Affairs Satellite Clinic - Sacramento, Sacramento, California 95820, United States

CCOP - Colorado Cancer Research Program, Inc., Denver, Colorado 80209-5031, United States

University of Colorado Cancer Center, Denver, Colorado 80262, United States

Hartford Hospital, Hartford, Connecticut 06102-5037, United States

CCOP - Christiana Care Health Services, Wilmington, Delaware 19899, United States

Baptist Regional Cancer Institute - Jacksonville, Jacksonville, Florida 32207, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida 33140, United States

MD Anderson Cancer Center Orlando, Orlando, Florida 32806, United States

Ocala Oncology Center, Ocala, Florida 34474, United States

Sarasota Memorial Hospital, Sarasota, Florida 34239, United States

Sylvester Cancer Center, University of Miami, Miami, Florida 33136, United States

CCOP - Atlanta Regional, Atlanta, Georgia 30342-1701, United States

Medical College of Georgia Comprehensive Cancer Center, Augusta, Georgia 30912-4000, United States

Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia 30033, United States

Winship Cancer Center, Atlanta, Georgia 30322, United States

Cancer Research Center of Hawaii, Honolulu, Hawaii 96813, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Central Illinois, Springfield, Illinois 62526, United States

CCOP - Evanston, Evanston, Illinois 60201, United States

Highland Park Hospital, Highland Park, Illinois 60035-2497, United States

Illinois Masonic Medical Center, Chicago, Illinois 60657, United States

Rockford Clinic, Rockford, Illinois 61103, United States

Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois 60612, United States

West Suburban Hospital Medical Center, Oak Park, Illinois 60302, United States

Community Hospitals of Indianapolis - Regional Cancer Center, Indianapolis, Indiana 46219, United States

Memorial Hospital of South Bend, South Bend, Indiana 46601, United States

Methodist Cancer Center - Indianapolis, Indianapolis, Indiana 46206-1367, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 10309-1016, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

University of Kansas Medical Center, Kansas City, Kansas 66160-7357, United States

Veterans Affairs Medical Center - Wichita, Wichita, Kansas 67218, United States

Baptist Hospital East - Louisville, Louisville, Kentucky 40207, United States

Lucille Parker Markey Cancer Center, University of Kentucky, Lexington, Kentucky 40536-0093, United States

Norton Healthcare System, Louisville, Kentucky 40202-5070, United States

CCOP - Ochsner, New Orleans, Louisiana 70121, United States

Louisiana State University Medical Center - New Orleans, New Orleans, Louisiana 70112, United States

Tulane University School of Medicine, New Orleans, Louisiana 70112, United States

Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana 70112, United States

Eastern Maine Medical Center, Bangor, Maine 04401, United States

Manitoba Cancer Treatment and Research Foundation, Winnipeg, Manitoba R3E 0V9, Canada

Franklin Square Hospital Center, Baltimore, Maryland 21237, United States

National Naval Medical Center, Bethesda, Maryland 20889-5000, United States

Regional Cancer Therapy Center - Frederick, Frederick, Maryland 21701, United States

Baystate Medical Center, Springfield, Massachusetts 01199, United States

Berkshire Medical Center, Pittsfield, Massachusetts 01201, United States

Boston Medical Center, Boston, Massachusetts 02118, United States

Lahey Clinic - Burlington, Burlington, Massachusetts 01805, United States

New England Medical Center Hospital, Boston, Massachusetts 02111, United States

CCOP - Ann Arbor Regional, Ann Arbor, Michigan 48106, United States

CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan 49503, United States

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States

Michigan State University, East Lansing, Michigan 48824, United States

Providence Hospital - Southfield, Southfield, Michigan 48075-9975, United States

CCOP - Duluth, Duluth, Minnesota 55805, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States

Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota 55415, United States

Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi 39534-2576, United States

CCOP - Kansas City, Kansas City, Missouri 64131, United States

CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri 63141, United States

Ellis Fischel Cancer Center - Columbia, Columbia, Missouri 65203, United States

St. Louis University School of Medicine, Saint Louis, Missouri 63104, United States

CCOP - Montana Cancer Consortium, Billings, Montana 59101, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68131, United States

Methodist Cancer Center - Omaha, Omaha, Nebraska 68114, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

CCOP - Northern New Jersey, Hackensack, New Jersey 07601, United States

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States

Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States

Veterans Affairs Medical Center - East Orange, East Orange, New Jersey 07018-1095, United States

University of New Mexico Cancer Research & Treatment Center, Albuquerque, New Mexico 87131, United States

Albany Regional Cancer Center, Albany, New York 12208, United States

CCOP - North Shore University Hospital, Manhasset, New York 11030, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York 13210, United States

Genesee Hospital - Rochester, Rochester, New York 14607, United States

Mount Sinai Medical Center, NY, New York, New York 10029, United States

State University of New York Health Science Center at Brooklyn, Brooklyn, New York 11203, United States

Staten Island University Hospital, Staten Island, New York 10305, United States

CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina 27104-4241, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157-1082, United States

East Carolina University School of Medicine, Greenville, North Carolina 27858-4354, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina 27599-7295, United States

CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States

Veterans Affairs Medical Center - Fargo, Fargo, North Dakota 58102, United States

Akron City Hospital, Akron, Ohio 44309, United States

Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio 43210, United States

Barrett Cancer Center, The University Hospital, Cincinnati, Ohio 45219, United States

CCOP - Columbus, Columbus, Ohio 43206, United States

CCOP - Dayton, Kettering, Ohio 45429, United States

CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio 43623-3456, United States

Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio 45220, United States

Jewish Hospital of Cincinnati, Inc., Cincinnati, Ohio 45236, United States

Meridia South Pointe Hospital, Cleveland, Ohio 44122, United States

Mount Sinai Medical Center - Cleveland, Cleveland, Ohio 44122, United States

Veterans Affairs Medical Center - Dayton, Dayton, Ohio 45428, United States

CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center, Tulsa, Oklahoma 74136, United States

St. Michael's Hospital - Toronto, Toronto, Ontario M5B 1W8, Canada

Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario M4N 3M5, Canada

CCOP - Columbia River Program, Portland, Oregon 97213, United States

Oregon Cancer Center at Oregon Health Sciences University, Portland, Oregon 97201-3098, United States

Albert Einstein Cancer Center, Philadelphia, Pennsylvania 19141, United States

Allegheny General Hospital, Pittsburgh, Pennsylvania 15212-4772, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania 19096, United States

Lehigh Valley Hospital, Allentown, Pennsylvania 18105-1556, United States

Penn State Geisinger Medical Center, Danville, Pennsylvania 17822-2001, United States

Reading Hospital and Medical Center, Reading, Pennsylvania 19612-6052, United States

St. Luke's Network - Bethlehem, Bethlehem, Pennsylvania 18015, United States

University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania 15213, United States

Veterans Affairs Medical Center - Pittsburgh, Pittsburgh, Pennsylvania 15240, United States

Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec H2W-W1T8, Canada

Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec, Quebec City, Quebec G1R 2J6, Canada

Hopital Laval, Ste-Foy, Quebec G1V 4G5, Canada

Jewish General Hospital - Montreal, Montreal, Quebec H3T 1E2, Canada

Montreal General Hospital, Montreal, Quebec H3G 1A4, Canada

Royal Victoria Hospital - Montreal, Montreal, Quebec H3A 1A1, Canada

Kent County Memorial Hospital - Rhode Island, Warwick, Rhode Island 02886, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

CCOP - Greenville, Greenville, South Carolina 29615, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

Medical University of South Carolina, Charleston, South Carolina 29425-0721, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57105-1080, United States

CCOP - Baptist Cancer Institute, Memphis, Tennessee 38117, United States

Veterans Affairs Medical Center - Memphis, Memphis, Tennessee 38104, United States

Kelsey Seybold Clinic, Houston, Texas 77025, United States

MBCCOP - South Texas Pediatric, San Antonio, Texas 78284-7810, United States

Medical Group of Texas, Dallas, Texas 75243, United States

University of Texas Health Center at Tyler, Tyler, Texas 75710, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78284, United States

Wilford Hall - 59th Medical Wing, Lackland Air Force Base, Texas 78236-5300, United States

Utah Valley Regional Medical Center - Provo, Provo, Utah 84604, United States

Eastern Virginia Medical School, Norfolk, Virginia 23507, United States

Massey Cancer Center, Richmond, Virginia 23298-0037, United States

MBCCOP - Massey Cancer Center, Richmond, Virginia 23298-0037, United States

Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke, Virginia 24014, United States

Veterans Affairs Medical Center - Richmond, Richmond, Virginia 23249, United States

Veterans Affairs Medical Center - Salem, Salem, Virginia 24153, United States

Virginia Oncology Associates, Newport News, Virginia 23606, United States

CCOP - Northwest, Tacoma, Washington 98405-0986, United States

CCOP - Virginia Mason Research Center, Seattle, Washington 98101, United States

Puget Sound Oncology Consortium, Seattle, Washington 98109, United States

Camden-Clark Memorial Hospital, Parkersburg, West Virginia 26102, United States

CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin 54449, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: June 1998
Last updated: May 23, 2008