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.

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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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Study ID:

NCT00002662

Recruitment Status:

Completed

Sponsor:

Aventis Pharmaceuticals

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There are 32 Locations for this study

See Locations Near You

Montclair Regional Cancer Center
Birmingham Alabama, 35213, United States
Highlands Oncology Group, P.A. - Fayetteville
Fayetteville Arkansas, 72703, United States
Northeast Arkansas Clinic
Jonesboro Arkansas, 72401, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
California Cancer Care, Inc.
Greenbrae California, 94904, United States
Green Cancer Center at Scripps Clinic
La Jolla California, 92037, United States
Sidney Kimmel Cancer Center
San Diego California, 92121, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver Colorado, 80010, United States
Norwich Cancer Center
Norwich Connecticut, 06360, United States
George Washington University Medical Center
Washington District of Columbia, 20037, United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville Florida, 32207, United States
Georgia Cancer Specialists - DeKalb
Decatur Georgia, 30033, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago Illinois, 60612, United States
James Graham Brown Cancer Center at University of Louisville
Louisville Kentucky, 40202, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough Maine, 04074, United States
Tufts - New England Medical Center
Boston Massachusetts, 02111, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Southfield Oncology Institute, Inc.
Southfield Michigan, 48076, United States
Mercy Arch Hematology Oncology, P.C.
Saint Louis Missouri, 63141, United States
Carolinas Hematology-Oncology Associates
Charlotte North Carolina, 28203, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte North Carolina, 28232, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio, 45267, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Hematology Oncology Consultants Inc
Columbus Ohio, 43235, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Oncology-Hematology Associates
Philadelphia Pennsylvania, 19107, United States
Roger Williams Medical Center
Providence Rhode Island, 02908, United States
Greenville Hospital System
Greenville South Carolina, 29605, United States
Baptist Regional Cancer Center - Knoxville
Knoxville Tennessee, 37901, United States
Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78284, United States
Medical College of Wisconsin Cancer Center
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Study ID:

NCT00002662

Recruitment Status:

Completed

Sponsor:


Aventis Pharmaceuticals

How clear is this clinincal trial information?

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