Breast Cancer Clinical Trial
Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer
Summary
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: Randomized phase III trial to study the effectiveness of paclitaxel or docetaxel in treating women with stage IIIB or metastatic breast cancer.
Full Description
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 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
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There are 32 Locations for this study
Birmingham Alabama, 35213, United States
Fayetteville Arkansas, 72703, United States
Jonesboro Arkansas, 72401, United States
Little Rock Arkansas, 72205, United States
Greenbrae California, 94904, United States
La Jolla California, 92037, United States
San Diego California, 92121, United States
Denver Colorado, 80010, United States
Norwich Connecticut, 06360, United States
Washington District of Columbia, 20037, United States
Jacksonville Florida, 32207, United States
Decatur Georgia, 30033, United States
Chicago Illinois, 60612, United States
Louisville Kentucky, 40202, United States
Scarborough Maine, 04074, United States
Boston Massachusetts, 02111, United States
Ann Arbor Michigan, 48109, United States
Southfield Michigan, 48076, United States
Saint Louis Missouri, 63141, United States
Charlotte North Carolina, 28203, United States
Charlotte North Carolina, 28232, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43235, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19107, United States
Providence Rhode Island, 02908, United States
Greenville South Carolina, 29605, United States
Knoxville Tennessee, 37901, United States
Dallas Texas, 75246, United States
San Antonio Texas, 78284, United States
Milwaukee Wisconsin, 53226, United States
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