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
18 Years
N/A
Both
Breast Cancer
Trial Information
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
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed stage II or IIIA breast cancer
- At least 5 axillary lymph nodes
- No T4 or N3 disease
- No distant metastases by CT scan of the chest, abdomen, and pelvis; bone scan; and
bone marrow evaluation
- No more than 8 weeks since prior lumpectomy or mastectomy with axillary node
dissection
- Negative surgical margins
- Hormone receptor status:
- Hormone receptor status known
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Male or female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,500/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 1.5 times ULN
- Alkaline phosphatase no greater than 1.5 times ULN
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No poorly controlled ischemic heart disease or congestive heart failure
Pulmonary:
- No severe chronic obstructive or restrictive pulmonary disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No severe diabetes mellitus
- No other severe concurrent medical or psychiatric illness that would preclude study
participation
- No other malignancy within past 5 years except curatively treated ductal carcinoma in
situ, lobular carcinoma in situ, or breast cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the safety of administering continuous infusion paclitaxel with dose intense cyclophosphamide
Outcome Description:
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.
Outcome Time Frame:
9 weeks
Safety Issue:
Yes
Principal Investigator
Brenda W. Cooper, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CWRU1100
NCT ID:
NCT00007904
Start Date:
July 2000
Completion Date:
September 2012
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage IIIA breast cancer
- male breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| UH-LUICC | Mentor, Ohio 44060 |
| UH-Chagrin Highlands | Orange Village, Ohio 44122 |
