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High-Dose Infusional Taxol, Amifostine, Doxorubicin, and Cyclophosphamide Followed by Stem Cell Rescue for High Risk Primary and Responsive Metastatic Breast Cancer

Phase 2
59 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

High-Dose Infusional Taxol, Amifostine, Doxorubicin, and Cyclophosphamide Followed by Stem Cell Rescue for High Risk Primary and Responsive Metastatic Breast Cancer

OBJECTIVES: I. Evaluate the feasibility of high dose doxorubicin, cyclophosphamide,
paclitaxel, and amifostine in patients with high risk stage II/III and responsive stage IV
advanced breast cancer. II. Determine the pharmacokinetic profile of paclitaxel administered
with amifostine in this regimen in these patients. III. Assess the toxicity of this
treatment regimen in this patient population.

OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously twice daily on days 1-4 for
peripheral blood stem cell (PBSC) mobilization and continuing through days 5-10 during PBSC
collection. At least 2 weeks following mobilization, patients receive doxorubicin IV as a
continuous infusion on days -9 through -5 followed by cyclophosphamide IV over 2 hours on
day -5 and amifostine IV over 15 minutes, and paclitaxel IV over 24 hours on day -4. On day
-2, 25% PBSC are reinfused and 75% are reinfused on day 0, followed by daily G-CSF
subcutaneously or IV beginning on day 1. Patients are followed every 3 months for 2 years,
then periodically thereafter.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 6-8 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven breast cancer including: Stage IV
metastatic disease with current partial or complete response to prior induction
chemotherapy High risk primary disease with less than 60% chance of progression free
survival at 3 years Stage II tumors with 10 or more axillary node involvement Stage IIIA
or IIIB tumors No bone marrow metastases No CNS metastases No more than 10 bone metastases
Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 59 and under Menopausal status: Not specified Performance
status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Neutrophil count
greater than 2,000/mm3 Platelet count greater than 150,000/mm3 Hemoglobin greater than 9
g/dL (blood transfusions allowed) Hepatic: Bilirubin no greater than 1.2 mg/dL SGOT or
SGPT less than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.2 mg/dL
Creatinine clearance at least 80 mL/min No prior hemorrhagic cystitis Cardiovascular:
Ejection fraction at least 55% by MUGA No prior valvular heart disease or arrhythmia
Pulmonary: DLCO at least 60% lower limit of predicted pCO2 no greater than 43 mmHg on room
air pO2 greater than 85 mmHg on room air FEV 1 at least 2 liters Other: No other prior
malignancy except basal or squamous cell skin cancer, or carcinoma in situ or stage I
carcinoma of the cervix Not pregnant HIV negative Hepatitis B negative No prior history of
disabling psychosocial disorder No other CNS dysfunction

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 4 weeks since prior chemotherapy No more than 2 prior
chemotherapy regimens for metastatic disease Prior total doxorubicin dose no greater than
180 mg/m2 Prior total paclitaxel dose no greater than 750 mg/m2 Endocrine therapy: At
least 4 weeks since prior hormonal therapy Radiotherapy: At least 4 weeks since prior
radiotherapy No prior radiotherapy to the left chest wall No prior radiotherapy to greater
than 20% of bone marrow (excluding syngeneic transplantation candidates) Surgery: Not

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

George Somlo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute


United States: Federal Government

Study ID:




Start Date:

March 1999

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms



Cancer Center and Beckman Research Institute, City of Hope Duarte, California  91010-3000