Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer
NCT ID: NCT00002662
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1994-08-31
2004-06-30
Brief Summary
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PURPOSE: Randomized phase III trial to study the effectiveness of paclitaxel or docetaxel in treating women with stage IIIB or metastatic breast cancer.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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docetaxel
paclitaxel
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Aventis Pharmaceuticals
INDUSTRY
Principal Investigators
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Peter M. Ravdin, MD
Role: STUDY_CHAIR
The University of Texas Health Science Center at San Antonio
Locations
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Montclair Regional Cancer Center
Birmingham, Alabama, United States
Highlands Oncology Group, P.A. - Fayetteville
Fayetteville, Arkansas, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
California Cancer Care, Inc.
Greenbrae, California, United States
Green Cancer Center at Scripps Clinic
La Jolla, California, United States
Sidney Kimmel Cancer Center
San Diego, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States
Norwich Cancer Center
Norwich, Connecticut, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, United States
Georgia Cancer Specialists - DeKalb
Decatur, Georgia, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States
Tufts - New England Medical Center
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Southfield Oncology Institute, Inc.
Southfield, Michigan, United States
Mercy Arch Hematology Oncology, P.C.
St Louis, Missouri, United States
Carolinas Hematology-Oncology Associates
Charlotte, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Hematology Oncology Consultants Inc
Columbus, Ohio, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Oncology-Hematology Associates
Philadelphia, Pennsylvania, United States
Roger Williams Medical Center
Providence, Rhode Island, United States
Greenville Hospital System
Greenville, South Carolina, United States
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, United States
Charles A. Sammons Cancer Center
Dallas, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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CDR0000064232
Identifier Type: REGISTRY
Identifier Source: secondary_id
RP-56976-TAX-311
Identifier Type: -
Identifier Source: secondary_id
NCI-V95-0680
Identifier Type: -
Identifier Source: secondary_id
AVENTIS-56976-TAX-311
Identifier Type: -
Identifier Source: org_study_id