A Phase II Study of Doxorubicin and Cyclophosphamide With Sequential Docetaxel in Patients With Hormone-Refractory Prostate Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the prostate that is
chemotherapy naive and refractory to hormonal therapy with combined androgen blockade No
concurrent antiandrogen therapy withdrawal: Must continue antiandrogen therapy until
completion of study OR Must discontinue flutamide at least 4 weeks before or bicalutamide
at least 8 weeks before study enrollment, and must have disease progression off
antiandrogen therapy, defined by serial increase in PSA (at least 2 measurements taken at
least 2 weeks apart) or measurable tumor Concurrent LHRH antagonist allowed if no prior
orchiectomy No minimum PSA level required Measurable or evaluable disease An increase in
PSA or pain without measurable or evaluable disease does not constitute hormone refractory
disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% ECOG 0-2
Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: SGOT
and SGPT no greater than 2 times upper limit of normal Bilirubin no greater than 2.0 mg/dL
Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: LVEF normal No impaired
cardiac status (e.g., history of severe heart disease, cardiomyopathy, or congestive heart
failure) Other: No active infection, defined by the following: Clinical syndrome
consistent with a viral or bacterial infection (e.g., influenza, upper respiratory
infection, or urinary tract infection) Fever with a clinical site of infection identified
Microbiologically documented infection including, but not limited to, bacteremia or
septicemia HIV negative No other malignancy within the past 5 years except surgically
cured basal cell or squamous cell skin cancer No psychiatric, addictive, or other disorder
that would preclude informed consent or compliance No hypersensitivity to E. coli derived
proteins or drugs formulated with polysorbate 80 (e.g., human insulin)

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent WBC transfusions No other
concurrent biologic therapy Chemotherapy: See Disease Characteristics No other concurrent
chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks
since prior radiotherapy Surgery: See Disease Characteristics Other: No other concurrent
investigational agent No concurrent acetaminophen for fever prophylaxis