RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with filgrastim and radiation therapy works in treating patients with stage II or stage IIIA breast cancer.
OBJECTIVES: * Determine the feasibility of administering adjuvant paclitaxel, dose-intensive cyclophosphamide, and filgrastim (G-CSF), followed by doxorubicin and then radiotherapy in patients with stage II or IIIA breast cancer involving \> 4 lymph nodes. * Determine the incidence of febrile neutropenia in these patients during the first course of therapy. * Compare the incidence of febrile neutropenia and duration of neutropenia in patients treated with this regimen with that seen in patients treated on protocol CWRU-4194. * Determine the disease-free and overall survival of patients treated with this regimen. * Evaluate the quality of life of these patients. * Correlate HER-2/neu overexpression with disease-free and overall survival in these patients. OUTLINE: Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses. Patients with hormone receptor positive disease also receive oral tamoxifen daily for 5 years beginning at the completion of chemotherapy. Beginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks. Quality of life is assessed days 1 and 4 of the first course of chemotherapy, day 1 of the second course, the last day of the final course, and at 6 months after the completion of treatment. Patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
Neupogen (G-CSF) given at a dose of 10 ugm/kg subcutaneously starting on day 5 and continuing until ANC \> 10,000/uL x1 day after the nadir cycles 1-3.
cyclophosphamide 700 mg/m2 daily for 3 day every 3 weeks cycles 1-3
Patients then receive doxorubicin IV on day 1.
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
UH-LUICC
Mentor, Ohio, United States
UH-Chagrin Highlands
Orange, Ohio, United States
To determine the safety of administering continuous infusion paclitaxel with dose intense cyclophosphamide
Paclitaxel 160 mg/m2 given over 72 hours by continuous infusion days 1-3 given concurrently with cyclophosphamide 700 mg/m2 daily for 3 day every 3 weeks cycles 1-3. Patients will be observed in the outpatient treatment area during the first 2 hours of the paclitaxel infusion for allergic reactions. Epinephrine, hydrocortisone, and IV antihistamine will be available.
Time frame: 9 weeks
To determine the incidence of febrile neutropenia with the first cycle of therapy.
A specific objective of this trial is to estimate the incidence of febrile neutropenia. The observed incidence of febrile neutropenia with the first cycle of cyclophosphamide and paclitaxel, as well as the observed number of days of grade ¾ neutropenia during the first treatment cycle, will be reported along with 95% confidence intervals.
Time frame: 3 weeks
To determine days of neutrophil counts below 500/uL on this regimen during the first treatment cycle.
Time frame: after 1st cycle (3 weeks)
To evaluate dose delays and dose reductions of this regimen.
Time frame: at 7 cycles (21 weeks)
To determine disease-free and overall survival of this regimen.
Time frame: 5 yrs after treatment
Quality of life as assessed by Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire
Quality of life will be assessed using the FACT-B instrument. Quality of life will be assessed at the following timepoints: Cycle 1 day 1, Cycle 1 day 4, Cycle 2 day 1, on the final day of adriamycin, and 6 months after treatment is completed.
Time frame: 6 months after treatment
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TREATMENT
Masking
NONE
Enrollment
16
Paclitaxel 160 mg/m2 given over 72 hours by continuous infusion days 1-3
tamoxifen at a dose of 20 mg daily for 5 years after chemotherapy is completed
Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses.
Beginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks.
Correlation of Her2/neu overexpression with disease-free and overall survival
Time frame: 5 yrs after treatment