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| Sponsor: | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003352 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 Start Date: | June 1998 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Baptist Medical Center - Birmingham | |
| Birmingham, Alabama, United States, 35213 | |
| Huntsville Hospital System | |
| Huntsville, Alabama, United States, 35801 | |
| MBCCOP - University of South Alabama | |
| Mobile, Alabama, United States, 36688 | |
| United States, Arizona | |
| CCOP - Greater Phoenix | |
| Phoenix, Arizona, United States, 85006-2726 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609-3305 | |
| CCOP - Santa Rosa Memorial Hospital | |
| Santa Rosa, California, United States, 95403 | |
| Kaiser Permanente Medical Center - Vallejo | |
| Vallejo, California, United States, 94589 | |
| Beckman Research Institute, City of Hope | |
| Duarte, California, United States, 91010 | |
| Naval Medical Center - Oakland | |
| Oakland, California, United States, 94627-5000 | |
| Naval Medical Center - San Diego | |
| San Diego, California, United States, 92134-3202 | |
| Saint Mary Medical Center - Long Beach | |
| Long Beach, California, United States, 90813-0887 | |
| Scripps Clinic and Research Foundation - La Jolla | |
| La Jolla, California, United States, 92037 | |
| Sutter Cancer Center | |
| Sacramento, California, United States, 95816 | |
| University of California San Diego Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| Veterans Affairs Medical Center - San Francisco | |
| San Francisco, California, United States, 94121 | |
| Veterans Affairs Satellite Clinic - Sacramento | |
| Sacramento, California, United States, 95820 | |
| United States, Colorado | |
| CCOP - Colorado Cancer Research Program, Inc. | |
| Denver, Colorado, United States, 80209-5031 | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| Hartford Hospital | |
| Hartford, Connecticut, United States, 06102-5037 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Wilmington, Delaware, United States, 19899 | |
| United States, Florida | |
| Baptist Regional Cancer Institute - Jacksonville | |
| Jacksonville, Florida, United States, 32207 | |
| CCOP - Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| MD Anderson Cancer Center Orlando | |
| Orlando, Florida, United States, 32806 | |
| Ocala Oncology Center | |
| Ocala, Florida, United States, 34474 | |
| Sarasota Memorial Hospital | |
| Sarasota, Florida, United States, 34239 | |
| Sylvester Cancer Center, University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| Medical College of Georgia Comprehensive Cancer Center | |
| Augusta, Georgia, United States, 30912-4000 | |
| Veterans Affairs Medical Center - Atlanta (Decatur) | |
| Decatur, Georgia, United States, 30033 | |
| Winship Cancer Center | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Central Illinois | |
| Springfield, Illinois, United States, 62526 | |
| CCOP - Evanston | |
| Evanston, Illinois, United States, 60201 | |
| West Suburban Hospital Medical Center | |
| Oak Park, Illinois, United States, 60302 | |
| Illinois Masonic Medical Center | |
| Chicago, Illinois, United States, 60657 | |
| Rockford Clinic | |
| Rockford, Illinois, United States, 61103 | |
| Rush-Presbyterian-St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Highland Park Hospital | |
| Highland Park, Illinois, United States, 60035-2497 | |
| United States, Indiana | |
| Community Hospitals of Indianapolis - Regional Cancer Center | |
| Indianapolis, Indiana, United States, 46219 | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| Methodist Cancer Center - Indianapolis | |
| Indianapolis, Indiana, United States, 46206-1367 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 10309-1016 | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| Veterans Affairs Medical Center - Wichita | |
| Wichita, Kansas, United States, 67218 | |
| United States, Kentucky | |
| Baptist Hospital East - Louisville | |
| Louisville, Kentucky, United States, 40207 | |
| Lucille Parker Markey Cancer Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0093 | |
| Norton Healthcare System | |
| Louisville, Kentucky, United States, 40202-5070 | |
| United States, Louisiana | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| Louisiana State University Medical Center - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane University School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| Veterans Affairs Medical Center - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maine | |
| Eastern Maine Medical Center | |
| Bangor, Maine, United States, 04401 | |
| United States, Maryland | |
| Franklin Square Hospital Center | |
| Baltimore, Maryland, United States, 21237 | |
| National Naval Medical Center | |
| Bethesda, Maryland, United States, 20889-5000 | |
| Regional Cancer Therapy Center - Frederick | |
| Frederick, Maryland, United States, 21701 | |
| United States, Massachusetts | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01199 | |
| Berkshire Medical Center | |
| Pittsfield, Massachusetts, United States, 01201 | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Lahey Clinic - Burlington | |
| Burlington, Massachusetts, United States, 01805 | |
| New England Medical Center Hospital | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| CCOP - Grand Rapids Clinical Oncology Program | |
| Grand Rapids, Michigan, United States, 49503 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| Michigan State University | |
| East Lansing, Michigan, United States, 48824 | |
| Providence Hospital - Southfield | |
| Southfield, Michigan, United States, 48075-9975 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Hennepin County Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55415 | |
| United States, Mississippi | |
| Keesler Medical Center - Keesler AFB | |
| Keesler AFB, Mississippi, United States, 39534-2576 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| CCOP - St. Louis-Cape Girardeau | |
| Saint Louis, Missouri, United States, 63141 | |
| Ellis Fischel Cancer Center - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| St. Louis University School of Medicine | |
| Saint Louis, Missouri, United States, 63104 | |
| United States, Montana | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68131 | |
| Methodist Cancer Center - Omaha | |
| Omaha, Nebraska, United States, 68114 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Jersey | |
| CCOP - Northern New Jersey | |
| Hackensack, New Jersey, United States, 07601 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Veterans Affairs Medical Center - East Orange | |
| East Orange, New Jersey, United States, 07018-1095 | |
| United States, New Mexico | |
| University of New Mexico Cancer Research & Treatment Center | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Albany Regional Cancer Center | |
| Albany, New York, United States, 12208 | |
| State University of New York Health Science Center at Brooklyn | |
| Brooklyn, New York, United States, 11203 | |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
| Syracuse, New York, United States, 13210 | |
| Genesee Hospital - Rochester | |
| Rochester, New York, United States, 14607 | |
| Mount Sinai Medical Center, NY | |
| New York, New York, United States, 10029 | |
| CCOP - North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Staten Island University Hospital | |
| Staten Island, New York, United States, 10305 | |
| United States, North Carolina | |
| CCOP - Southeast Cancer Control Consortium | |
| Winston-Salem, North Carolina, United States, 27104-4241 | |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| East Carolina University School of Medicine | |
| Greenville, North Carolina, United States, 27858-4354 | |
| Lineberger Comprehensive Cancer Center, UNC | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| United States, North Dakota | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| Veterans Affairs Medical Center - Fargo | |
| Fargo, North Dakota, United States, 58102 | |
| United States, Ohio | |
| Akron City Hospital | |
| Akron, Ohio, United States, 44309 | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| Barrett Cancer Center, The University Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| CCOP - Dayton | |
| Kettering, Ohio, United States, 45429 | |
| CCOP - Toledo Community Hospital Oncology Program | |
| Toledo, Ohio, United States, 43623-3456 | |
| Good Samaritan Hospital - Cincinnati | |
| Cincinnati, Ohio, United States, 45220 | |
| Jewish Hospital of Cincinnati, Inc. | |
| Cincinnati, Ohio, United States, 45236 | |
| Meridia South Pointe Hospital | |
| Cleveland, Ohio, United States, 44122 | |
| Mount Sinai Medical Center - Cleveland | |
| Cleveland, Ohio, United States, 44122 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| United States, Oklahoma | |
| CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| CCOP - Columbia River Program | |
| Portland, Oregon, United States, 97213 | |
| Oregon Cancer Center at Oregon Health Sciences University | |
| Portland, Oregon, United States, 97201-3098 | |
| United States, Pennsylvania | |
| Albert Einstein Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212-4772 | |
| CCOP - MainLine Health | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Lehigh Valley Hospital | |
| Allentown, Pennsylvania, United States, 18105-1556 | |
| Penn State Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| Reading Hospital and Medical Center | |
| Reading, Pennsylvania, United States, 19612-6052 | |
| St. Luke's Network - Bethlehem | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Veterans Affairs Medical Center - Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15240 | |
| United States, Rhode Island | |
| Kent County Memorial Hospital - Rhode Island | |
| Warwick, Rhode Island, United States, 02886 | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| United States, South Dakota | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57105-1080 | |
| United States, Tennessee | |
| CCOP - Baptist Cancer Institute | |
| Memphis, Tennessee, United States, 38117 | |
| Veterans Affairs Medical Center - Memphis | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| Kelsey Seybold Clinic | |
| Houston, Texas, United States, 77025 | |
| MBCCOP - South Texas Pediatric | |
| San Antonio, Texas, United States, 78284-7810 | |
| Medical Group of Texas | |
| Dallas, Texas, United States, 75243 | |
| University of Texas Health Center at Tyler | |
| Tyler, Texas, United States, 75710 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284 | |
| Wilford Hall - 59th Medical Wing | |
| Lackland Air Force Base, Texas, United States, 78236-5300 | |
| United States, Utah | |
| Utah Valley Regional Medical Center - Provo | |
| Provo, Utah, United States, 84604 | |
| United States, Virginia | |
| Eastern Virginia Medical School | |
| Norfolk, Virginia, United States, 23507 | |
| Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Virginia Oncology Associates | |
| Newport News, Virginia, United States, 23606 | |
| Oncology and Hematology Associates of Southwest Virginia, Inc. | |
| Roanoke, Virginia, United States, 24014 | |
| Veterans Affairs Medical Center - Richmond | |
| Richmond, Virginia, United States, 23249 | |
| Veterans Affairs Medical Center - Salem | |
| Salem, Virginia, United States, 24153 | |
| MBCCOP - Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| United States, Washington | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| CCOP - Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
| Puget Sound Oncology Consortium | |
| Seattle, Washington, United States, 98109 | |
| United States, West Virginia | |
| Camden-Clark Memorial Hospital | |
| Parkersburg, West Virginia, United States, 26102 | |
| United States, Wisconsin | |
| CCOP - Marshfield Medical Research and Education Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Tom Baker Cancer Center - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Manitoba | |
| Manitoba Cancer Treatment and Research Foundation | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Ontario | |
| St. Michael's Hospital - Toronto | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| Centre Hospitalier de l'Universite de Montreal | |
| Montreal, Quebec, Canada, H2W-W1T8 | |
| Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec | |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| Hopital Laval | |
| Ste-Foy, Quebec, Canada, G1V 4G5 | |
| Jewish General Hospital - Montreal | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Montreal General Hospital | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Royal Victoria Hospital - Montreal | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Puerto Rico | |
| MBCCOP - San Juan | |
| San Juan, Puerto Rico, 00927-5800 | |
| Veterans Affairs Medical Center - San Juan | |
| San Juan, Puerto Rico, 00927-5800 | |
| Study Chair: | Terry Mamounas, MD, MPH, FACS | Aultman Cancer Center at Aultman Hospital |
More Information
| Study ID Numbers: | CDR0000066333, NSABP-BP-58 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003352 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer stage IIIB breast cancer |
|
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide Antibiotics, Antineoplastic Immunosuppressive Agents Doxorubicin |
Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
