High Dose Paclitaxel Added to Cyclophosphamide and Thiotepa Followed by Autologous Stem Cell Rescue: A Phase I Trial in Advanced Breast Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven stage III or IV breast cancer Must have
responding disease (at least 50% reduction in the sum of the products of all diameters of
measurable nonbony lesions and at least symptomatic improvement in painful bone disease)
following conventional dose chemotherapy Asymptomatic patients with bony disease eligible
if no new lesions or other evidence of bone progression If only bone disease present,
there must be no new bony lesions following cytoreductive chemotherapy Patients who are
disease free following surgery (e.g., stage III patients or solitary lymph node patients
following excisional biopsy) eligible No CNS disease Hormone receptor status: Not
specified

PATIENT CHARACTERISTICS: Age: Physiologic 60 and under Menopausal status: Not specified
Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute
neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at
least 8.0 g/dL Hepatic: Bilirubin less than 2.5 times normal unless due to Gilbert's
syndrome SGOT or SGPT less than 2.5 times normal Alkaline phosphatase less than 2.5 times
normal If hepatitis C antibody positive, then liver function must be normal OR liver
dysfunction must be due to metastatic disease and not chronic hepatitis Renal: Creatinine
less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: LVEF at
least 50% unless cleared by cardiologist No myocardial infarction within the past 6 months
No significant arrhythmia requiring medications No congestive heart failure Pulmonary:
DLCO at least 50% predicted FEV1 and/or FVC at least 75% predicted unless due to
neoplastic pulmonary involvement No serious nonneoplastic pulmonary disease (severe
chronic obstructive lung disease) that would preclude study therapy Other: HIV negative
Hepatitis B and C surface antigen negative No active serious medical condition that would
preclude study therapy No allergy to Cremophor Not pregnant or nursing Negative pregnancy
test

PRIOR CONCURRENT THERAPY: No more than 3 prior treatment regimens for metastatic disease
Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Prior
conventional dose chemotherapy as adjuvant or as treatment for advanced disease allowed
Prior doxorubicin greater than 450 mg/m2 allowed if dexrazoxane was used to reduce risk of
cardiotoxicity At least 3 weeks since prior chemotherapy Endocrine therapy: Not specified
Radiotherapy: No prior radiotherapy to indicator lesions At least 3 weeks since other
prior radiotherapy Surgery: See Disease Characteristics At least 3 weeks since prior
surgery