Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
NCT ID: NCT00025688
Last Updated: 2008-07-24
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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UNKNOWN
PHASE3
INTERVENTIONAL
2001-01-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with or without carboplatin in treating women who have stage IV breast cancer.
Detailed Description
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* Compare the objective response rate in women treated with paclitaxel with or without carboplatin as first-line chemotherapy for metastatic breast cancer.
* Compare the overall survival, time to disease progression, and duration of response in these patients treated with these regimens.
* Compare the safety of these regimens in this patient population.
* Compare the quality of life of these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior adjuvant chemotherapy (yes vs no) and ECOG performance status (0-1 vs 2). Patients are randomized to one of two treatment arms.
* Arm I: Patients receive paclitaxel IV over 1 hour weekly for 3 weeks.
* Arm II:Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 3 weeks.
Treatment in both arms continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each course during study, and then after completion of study.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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carboplatin
paclitaxel
Eligibility Criteria
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Inclusion Criteria
* Patients with disease progression after prior response to hormonal therapy are eligible
* Disease progression without prior hormonal therapy is allowed
* Stable or asymptomatic brain metastasis allowed if:
* Other measurable disease exists
* Cranial irradiation completed and brain metastasis stable for at least 4 weeks before study
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Female
Menopausal status:
* Pre- or post-menopausal
Performance status:
* ECOG 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 2 times ULN
Renal:
* Creatinine no greater than 2 times ULN
* Corrected calcium less than 12 mg/dL
Cardiovascular:
* No New York Heart Association class III or IV heart disease
* No documented myocardial infarction within the past 6 months
* No congestive heart failure
* No unstable angina
* No clinically significant pericardial effusion or arrhythmia
Other:
* No active serious infection
* No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporine, or vitamin K
* No clinically significant (greater than grade 1) peripheral neuropathy
* No other serious underlying medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* More than 6 months since prior adjuvant bone marrow or peripheral blood stem cell transplantation
* More than 6 months since prior adjuvant monoclonal antibody therapy
* More than 6 months since prior adjuvant vaccine therapy
* No prior trastuzumab (Herceptin)
* No concurrent anticancer immunotherapy
Chemotherapy:
* No prior chemotherapy for metastatic breast cancer
* More than 6 months since prior adjuvant high-dose chemotherapy
* More than 6 months since prior adjuvant taxanes or any other adjuvant chemotherapy
* Prior adjuvant taxanes allowed only if administered every 3 weeks
Endocrine therapy:
* See Disease Characteristics
* Any number of prior hormonal therapies for metastatic breast cancer allowed
* Patients with definite signs of progression may begin study therapy immediately after stopping hormonal therapy
* No concurrent anticancer hormonal agents (including megestrol)
Radiotherapy:
* At least 3 weeks since prior radiotherapy (4 weeks for cranial irradiation)
* No prior radiotherapy to 30% or more of bone marrow
* No concurrent radiotherapy except for palliation of painful bone metastasis or pathologic fractures to the area of known lytic disease
Surgery:
* At least 3 weeks since prior major surgery
Other:
* More than 6 months since prior neoadjuvant therapy
* No other concurrent anticancer drugs
18 Years
FEMALE
No
Sponsors
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Theradex
INDUSTRY
Principal Investigators
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Edith A. Perez, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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Highlands Oncology Group
Springdale, Arkansas, United States
Monterey Bay Oncology
Monterey, California, United States
Wilshire Oncology Medical Group, Inc.
Pomona, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
New Britain General Hospital
New Britain, Connecticut, United States
Center for Hematology and Oncology
Boca Raton, Florida, United States
Cancer Research Network, Inc.
Hollywood, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
MacNeal Cancer Center
Berwyn, Illinois, United States
Oncology Specialists, SC
Park Ridge, Illinois, United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States
Maryland Hematology/Oncology Associates
Baltimore, Maryland, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
St. Barnabas Medical Center
Livingston, New Jersey, United States
Finger Lakes Community Cancer Center
Clifton Springs, New York, United States
Clinical Hematology & Oncology Service, Inc.
Akron, Ohio, United States
Scranton Hematology-Oncology
Scranton, Pennsylvania, United States
East Tennessee Oncology/Hematology, P.C.
Knoxville, Tennessee, United States
West Clinic
Memphis, Tennessee, United States
Texas Cancer Care
Fort Worth, Texas, United States
Oncology Consultants
Houston, Texas, United States
Scott and White Clinic
Temple, Texas, United States
Northern Virginia Oncology Group, P.C.
Fairfax, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Dean Medical Center
Madison, Wisconsin, United States
Countries
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Other Identifiers
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THERADEX-B00-1370
Identifier Type: -
Identifier Source: secondary_id
BMS-TAX/MEN.13
Identifier Type: -
Identifier Source: secondary_id
CDR0000068992
Identifier Type: -
Identifier Source: org_study_id