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Home > "P" Clinical Trials Conditions > Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer  Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): Theradex ,
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 if paclitaxel is more effective with or without carboplatin in treating stage IV breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with or without carboplatin in treating women who have stage IV breast cancer.
Details: OBJECTIVES: I. Compare the objective response rate in women treated with paclitaxel with or without carboplatin as first-line chemotherapy for metastatic breast cancer. II. Compare the overall survival, time to disease progression, and duration of response in these patients treated with these regimens. III. Compare the safety of these regimens in this patient population. IV. Compare the quality of life of these patients treated with these regimens. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically or cytologically confirmed breast cancer - Must have clinical evidence of stage IV (M1) disease HER-2/neu negative (0, 1+, or 2+ by immunohistochemistry or fluorescent in situ hybridization) OR status unknown At least 1 measurable lesion - At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan - Patients with bone-only disease are not eligible Ineligible if currently experiencing a complete or partial response to prior hormonal therapy 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 --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 --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/mm3 - Platelet count at least 100,000/mm3 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdithPerez, Study Chair, Theradex
Monterey Bay Oncology
Monterey, California, 93940
United States
Texas Cancer Care
Ft. Worth, Texas, 76104
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Dean Medical Center
Madison, Wisconsin, 53715
United States
Clinical Hematology & Oncology Service, Inc.
Akron, Ohio, 44302
United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109
United States
Scranton Hematology-Oncology
Scranton, Pennsylvania, 18510
United States
Cancer Research Network, Inc.
Hollywood, Florida, 33020
United States
Oncology Specialists, SC
Park Ridge, Illinois, 60068
United States
Finger Lakes Community Cancer Center
Clifton Springs, New York, 14432
United States
New Britain General Hospital
New Britain, Connecticut, 06050
United States
Center for Hematology and Oncology
Boca Raton, Florida, 33486
United States
Scott and White Clinic
Temple, Texas, 76508
United States
St. Barnabas Medical Center
Livingston, New Jersey, 07039
United States
Northern Virginia Oncology Group, P.C.
Fairfax, Virginia, 22031
United States
St. John's Mercy Medical Center
St. Louis, Missouri, 63141
United States
West Clinic
Memphis, Tennessee, 38120
United States
Maryland Hematology/Oncology Associates
Baltimore, Maryland, 21236
United States
Wilshire Oncology Medical Group, Inc.
Pomona, California, 91767-3021
United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, 04074
United States
MacNeal Cancer Center
Berwyn, Illinois, 60402
United States
Oncology Consultants
Houston, Texas, 77024
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
East Tennessee Oncology/Hematology, P.C.
Knoxville, Tennessee, 37920
United States
Highlands Oncology Group
Springdale, Arkansas, 72764
United States
Additional Information:
Study ID Numbers: CDR0000068992; THERADEX-B00-1370,BMS-TAX/MEN.13
Study Start Date: January 2001
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025688
Other Stage 4 Breast Cancer Studies:
1. Chemotherapy in Treating Women With Metastatic Breast Cancer
2. Combination Chemotherapy and Trastuzumab in Treating Women With Metastatic Breast Cancer
3. Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases
4. Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer
5. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
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