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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

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 CenterCleveland, Ohio  44106-5065
UH-LUICCMentor, Ohio  44060
UH-Chagrin HighlandsOrange Village, Ohio  44122