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Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer Clinical research trials and Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer. Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer  Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer
Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer
For Condition: recurrent breast cancer,stage 3B breast cancer,stage 4 breast cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , National Surgical Adjuvant Breast and Bowel Project (NSABP)
Synopsis: 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.
Details: OBJECTIVES: I. Determine the overall response rate to doxorubicin, docetaxel, and cyclophosphamide (ATC) in patients 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TerryMamounas, Study Chair, National Surgical Adjuvant Breast and Bowel Project (NSABP)
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Veterans Affairs Medical Center - Salem
Salem, Virginia, 24153
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Loma Linda University Medical Center
Loma Linda, California, 92354
United States
Hopital Laval
Ste Foy, Quebec, G1V 4G5
Canada
Eastern Maine Medical Center
Bangor, Maine, 04401
United States
Kent County Memorial Hospital - Rhode Island
Warwick, Rhode Island, 02886
United States
MBCCOP - San Juan
San Juan, , 00927-5800
Puerto Rico
East Carolina University School of Medicine
Greenville, North Carolina, 27858-4354
United States
Penn State Geisinger Medical Center
Danville, Pennsylvania, 17822-2001
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
Medical Group of Texas
Dallas, Texas, 75243
United States
Sutter Cancer Center
Sacramento, California, 95816
United States
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
United States
Community Hospitals of Indianapolis - Regional Cancer Center
Indianapolis, Indiana, 46219
United States
Genesee Hospital - Rochester
Rochester, New York, 14607
United States
Scripps Clinic and Research Foundation - La Jolla
La Jolla, California, 92037
United States
National Naval Medical Center
Bethesda, Maryland, 20889-5000
United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141
United States
Winship Cancer Center
Atlanta, Georgia, 30322
United States
Methodist Cancer Center - Indianapolis
Indianapolis, Indiana, 46206-1367
United States
Louisiana State University Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
University of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico, 87131
United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604
United States
Huntsville Hospital System
Huntsville, Alabama, 35801
United States
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
University of Texas Health Center at Tyler
Tyler, Texas, 75710
United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80209-5031
United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239
United States
Ocala Oncology Center
Ocala, Florida, 34474
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284
United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
United States
Virginia Oncology Associates
Newport News, Virginia, 23606
United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
MD Anderson Cancer Center Orlando
Orlando, Florida, 32806
United States
St. Luke's Network - Bethlehem
Bethlehem, Pennsylvania, 18015
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
Albany Regional Cancer Center
Albany, New York, 12208
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Jewish General Hospital - Montreal
Montreal, Quebec, H3T 1E2
Canada
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, 32207
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, 15240
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, 94589
United States
Michigan State University
East Lansing, Michigan, 48824
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
Methodist Cancer Center - Omaha
Omaha, Nebraska, 68114
United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
United States
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, 78236-5300
United States
Saint Mary Medical Center - Long Beach
Long Beach, California, 90813-0887
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Veterans Affairs Medical Center - San Juan
San Juan, , 00927-5800
Puerto Rico
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
Quebec City, Quebec, G1R 2J6
Canada
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
United States
Puget Sound Oncology Consortium
Seattle, Washington, 98109
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
Beckman Research Institute, City of Hope
Duarte, California, 91010
United States
Veterans Affairs Satellite Clinic - Sacramento
Sacramento, California, 95820
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
University of Colorado Cancer Center
Denver, Colorado, 80262
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
CCOP - Dayton
Kettering, Ohio, 45429
United States
Akron City Hospital
Akron, Ohio, 44309
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
Franklin Square Hospital Center
Baltimore, Maryland, 21237
United States
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, 74136
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Naval Medical Center - San Diego
San Diego, California, 92134-3202
United States
Baptist Medical Center - Birmingham
Birmingham, Alabama, 35213
United States
CCOP - Baptist Cancer Institute
Memphis, Tennessee, 38117
United States
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Mount Sinai Medical Center - Cleveland
Cleveland, Ohio, 44122
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
Kelsey Seybold Clinic
Houston, Texas, 77025
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Manitoba Cancer Treatment and Research Foundation
Winnipeg, Manitoba, R3E 0V9
Canada
MBCCOP - University of South Alabama
Mobile, Alabama, 36688
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105-1556
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
Berkshire Medical Center
Pittsfield, Massachusetts, 01201
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Canada
Naval Medical Center - Oakland
Oakland, California, 94627-5000
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Regional Cancer Therapy Center - Frederick
Frederick, Maryland, 21701
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 10309-1016
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507
United States
Illinois Masonic Medical Center
Chicago, Illinois, 60657
United States
Royal Victoria Hospital - Montreal
Montreal, Quebec, H3A 1A1
Canada
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
St. Louis University School of Medicine
St. Louis, Missouri, 63104
United States
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, 26102
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
Norton Healthcare System
Louisville, Kentucky, 40202-5070
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
CCOP - Central Illinois
Springfield, Illinois, 62526
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Hartford Hospital
Hartford, Connecticut, 06102-5037
United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
United States
New England Medical Center Hospital
Boston, Massachusetts, 02111
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Lahey Clinic - Burlington
Burlington, Massachusetts, 01805
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
Highland Park Hospital
Highland Park, Illinois, 60035-2497
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
West Suburban Hospital Medical Center
Oak Park, Illinois, 60302
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Staten Island University Hospital
Staten Island, New York, 10305
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
MBCCOP - South Texas Pediatric
San Antonio, Texas, 78284-7810
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, 97201-3098
United States
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
United States
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8
Canada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Meridia South Pointe Hospital
Cleveland, Ohio, 44122
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13210
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, 40536-0093
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2W-W1T8
Canada
CCOP - Columbia River Program
Portland, Oregon, 97213
United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
Jewish Hospital of Cincinnati, Inc.
Cincinnati, Ohio, 45236
United States
Rockford Clinic
Rockford, Illinois, 61103
United States
Medical College of Georgia Comprehensive Cancer Center
Augusta, Georgia, 30912-4000
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Additional Information:
Study ID Numbers: CDR0000066333; NSABP-BP-58
Study Start Date: June 1998
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003352
Other Stage 4 Breast Cancer Studies:
1. Docetaxel and Epirubicin With and Without G-CSF in Treating Women With Metastatic Breast Cancer
2. Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery
3. Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
4. Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer
5. BMS-247550 Plus Capecitabine in Treating Patients With Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other California Clinical Trials
Other Duarte Clinical Trials
Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer
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