A Phase II Study Of Safety And Tolerability Of Adjuvant Chemotherapy With Continuous Infusion Paclitaxel And Dose Intense Cyclophosphamide And Hematopoietic Growth Factor Support Followed By Doxorubicin For Stage II-IIIA Breast Cancer Involving Greater Than or Equal to 10 Lymph Nodes
- 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
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
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Brenda W. Cooper, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|UH-LUICC||Mentor, Ohio 44060|
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