|
Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer Clinical research trials and Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer medical trials happen in hundreds of localities throughout 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 typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer. Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer  Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer
Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer
For Condition: stage 4 breast cancer,stage 3A breast cancer,recurrent breast cancer,stage 3B breast cancer,stage 3C breast cancer
Status: Recruiting
Sponsor(s): Aventis Pharmaceuticals ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether paclitaxel is more effective than docetaxel for breast cancer. PURPOSE: Randomizedphase III trial to study the effectiveness of paclitaxel or docetaxel in treating women with stage IIIB or metastatic breast cancer.
Details: OBJECTIVES: - Compare the response rate in women with metastatic or locally advanced, inoperable adenocarcinoma of the breast treated with docetaxel vs paclitaxel. - Compare the toxicity of these regimens in these patients. - Compare the time to disease progression, duration of response, quality of life, and survival of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive paclitaxel IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and after courses 4 and 6. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven metastatic or locally advanced, inoperable adenocarcinoma of the breast - Clinically evident metastases (e.g., clearly malignant lesions on chest x-ray or CT or abdominal CT do not require histologic confirmation) - Hot spots on bone scan not shown to be malignant on plain x-rays are not adequate evidence of malignant disease in the absence of other lesions - Must meet 1 of the following conditions: - Disease progression after 1 prior chemotherapy regimen for locally advanced or metastatic disease (which may or may not have followed a separate adjuvant regimen using chemotherapy or hormonal therapy) - Locally advanced or metastatic disease during or after 1 adjuvant or neoadjuvant chemotherapy regimen - One of the above chemotherapy regimens must have contained an anthracycline (e.g., doxorubicin, but not mitoxantrone) - Single drug substitution (e.g., methotrexate for doxorubicin) during prior combination chemotherapy allowed - Bidimensionally measurable - No clinical or radiographic evidence of brain or leptomeningeal disease - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Not specified Performance status: - Karnofsky 60-100% OR - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 2,000/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin normal - SGOT no greater than 2.5 times upper limit of normal Renal: - Creatinine no greater than 2.0 mg/dL - No uncontrolled hypercalcemia Cardiovascular: - No myocardial infarction within the past 6 months - No history of arrhythmia requiring treatment - No heart block - No clinical evidence of congestive heart failure - No unstable angina (e.g., new onset, crescendo, or rest angina) - Stable exertional angina allowed Other: - No current symptomatic grade 2 or greater peripheral neuropathy - No history of hypersensitivity to products containing Cremophor EL (e.g., cyclosporine or teniposide) or Polysorbate 80 (e.g., IV etoposide) - No serious infection - No significant psychiatric disease that would preclude study - No other malignancy within the past 5 years except nonmelanomatous skin cancer or completely excised carcinoma in situ of the cervix - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior bone marrow or stem cell transplantation Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior chemotherapy (2 weeks for oral cyclophosphamide or 6 weeks for nitrosoureas or mitomycin) - No prior high-dose chemotherapy given with ablative intent - No prior taxoids - No other concurrent antineoplastic therapy Endocrine therapy: - See Disease Characteristics - Prior hormonal therapy as adjuvant therapy or for metastatic disease allowed - At least 1 week since prior hormonal therapy - No concurrent corticosteroids except: - Prophylaxis or treatment for acute hypersensitivity reactions - Chronic therapy (more than 6 months) at low doses (20 mg/day or less of methylprednisolone or equivalent) Radiotherapy: - At least 4 weeks since prior radiotherapy to major bone marrow areas - No prior high-dose radiotherapy given with ablative intent - No concurrent radiotherapy except limited palliative radiotherapy (e.g., for a solitary rib fracture) during objective response Surgery: - See Disease Characteristics - More than 2 weeks since prior surgery except simple biopsy or placement of venous access device Other: - At least 4 weeks since prior investigational drugs - Concurrent medications known to alter cardiac conduction (e.g., digoxin, beta blockers, or calcium channel blockers) allowed - No concurrent ketoconazole - No concurrent bisphosphonates unless initiated more than 3 months before randomization - No concurrent experimental drug or therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterRavdin, Study Chair, University of Texas
Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati, Ohio, 45267-0501
United States
Recruiting Elyse Lower 513-584-7661
Hematology Oncology Consultants Inc *Recruiting*
Columbus, Ohio, 43235
United States
Recruiting Leslie Laufman 614-846-0044 ext. 3104
Roger Williams Medical Center *Recruiting*
Providence, Rhode Island, 02908-4735
United States
Recruiting Alan Weitberg 401-456-2070
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226-3596
United States
Recruiting David Vesole 414-805-4646
California Cancer Care, Inc. *Recruiting*
Greenbrae, California, 94904-2007
United States
Recruiting Peter Eisenberg 415-925-5000
Oncology-Hematology Associates *Recruiting*
Philadelphia, Pennsylvania, 19107
United States
Recruiting Patricia Ford 215-829-6088
Mercy Arch Hematology Oncology, P.C. *Recruiting*
St. Louis, Missouri, 63141
United States
Recruiting Alex Denes 314-569-6954
Northeast Arkansas Clinic *Recruiting*
Jonesboro, Arkansas, 72401-3125
United States
Recruiting Ronald Blachly 870-935-4150
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Denver, Colorado, 80010
United States
Recruiting Douglas Rovira 303-270-8801
Baptist Regional Cancer Center - Knoxville *Recruiting*
Knoxville, Tennessee, 37901
United States
Recruiting Tracy Dobbs 865-632-5717
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting John Erban 617-636-5147
Rush-Presbyterian-St. Luke's Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Sarah Lincoln 312-563-2537
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0942
United States
Recruiting Sofia Merajver 313-747-3421
Green Cancer Center at Scripps Clinic *Recruiting*
La Jolla, California, 92037
United States
Recruiting Joel Bernstein 858-554-8533
Highlands Oncology Group, P.A. - Fayetteville *Recruiting*
Fayetteville, Arkansas, 72703
United States
Recruiting Joseph Beck 479-587-1700
Maine Center for Cancer Medicine and Blood Disorders - Scarborough *Recruiting*
Scarborough, Maine, 04074
United States
Recruiting Thomas Ervin 207-885-7600
George Washington University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20037
United States
Recruiting Robert Siegel 202-741-2210
Charles A. Sammons Cancer Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Stephen Jones 214-370-1795
James Graham Brown Cancer Center at University of Louisville *Recruiting*
Louisville, Kentucky, 40202
United States
Recruiting John Hamm 502-562-4369
Blumenthal Cancer Center at Carolinas Medical Center *Recruiting*
Charlotte, North Carolina, 28232-2861
United States
Recruiting Warden Woodard 704-355-3789
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Harold Harvey 717-531-8677
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Laura Hutchins 501-686-8511
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Beth Overmoyer 216-445-6066
Carolinas Hematology-Oncology Associates *Recruiting*
Charlotte, North Carolina, 28203
United States
Recruiting Steven Limentani 704-446-9046
Sidney Kimmel Cancer Center *Recruiting*
San Diego, California, 92121
United States
Recruiting John Gutheil 619-450-5998, ext. 270
Montclair Regional Cancer Center *Recruiting*
Birmingham, Alabama, 35213
United States
Recruiting Jimmie Harvey 205-592-5077
Baptist Regional Cancer Institute - Jacksonville *Recruiting*
Jacksonville, Florida, 32207-8554
United States
Recruiting Neil Abramson 904-202-7048
Norwich Cancer Center *Recruiting*
Norwich, Connecticut, 06360
United States
Recruiting Mandeep Dhami 860-886-8362
Greenville Hospital System *Recruiting*
Greenville, South Carolina, 29605
United States
Recruiting Mark O'Rourke 803-455-8752
Georgia Cancer Specialists - DeKalb *Recruiting*
Decatur, Georgia, 30033
United States
Recruiting Melvin Moore 404-501-7725
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78284-7811
United States
Recruiting Peter Ravdin 210-567-4777
Southfield Oncology Institute, Inc. *Recruiting*
Southfield, Michigan, 48076-3779
United States
Recruiting Clarence Vaughn 248-356-2828
Additional Information:
Study ID Numbers: CDR0000064232; AVENTIS-56976-TAX-311,RP-56976-TAX-311,NCI-V95-0680
Study Start Date:
Record last reviewed: May 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002662
Other Stage 3c Breast Cancer Studies:
1. Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer
2. Combination Chemotherapy, Monoclonal Antibody Therapy, and Surgery in Treating Women With Stage II, Stage III, or Stage IV Breast Cancer
3. Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
4. Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
5. Epirubicin and Tamoxifen With or Without Docetaxel in Treating Postmenopausal Women With Breast Cancer
Related Studies:
Other stage 3C breast cancer Clinical Trials
Other Tennessee Clinical Trials
Other Knoxville Clinical Trials
Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer
|
|
|
|
|
|
|
|
