A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Hormone-Refractory Prostate Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed prostate carcinoma
Metastatic disease Documented progression of prostate cancer while receiving androgen
ablative therapy (i.e., surgical or chemical castration and a serum testosterone level in
the castrate range) Documented hormone therapy resistance defined as: PSA rise on 3
occasions not less than 4 weeks apart Any evidence of progressive measurable disease PSA
must be above 20 ng/mL prior to study entry No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hemoglobin at
least 9.0 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5
mg/dL SGOT/SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver
metastases present) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active
congestive heart failure No uncontrolled angina No myocardial infarction within the past 6
months Other: Fertile patients must use effective contraception No uncontrolled pain
requiring irradiation No concurrent serious infection No other malignancy within the past
5 years except nonmelanoma skin cancer No overt psychosis, mental disability, or
incompetence

PRIOR CONCURRENT THERAPY: Biologic therapy: No prophylactic colony stimulating factors to
prevent neutropenia No concurrent biologic therapy Chemotherapy: No more than 1 prior
cytotoxic chemotherapy regimen No concurrent cytotoxic chemotherapy Endocrine therapy: See
Disease Characteristics At least 6 weeks since prior peripheral antiandrogens (e.g.,
flutamide) No concurrent steroid therapy initiated within past 2 months Current LHRH
agonist therapy should continue through study Radiotherapy: At least 4 weeks since prior
radiotherapy (except low dose, non myelosuppressive) and recovered No prior irradiation to
greater than 25% of bone marrow No prior strontium chloride Sr 89 or samarium Sm 153
lexidronam pentasodium No concurrent radiotherapy Surgery: See Disease Characteristics At
least 4 weeks since prior major surgery and recovered No concurrent surgery Other: No
other concurrent anticancer treatment At least 28 days since investigational drugs,
including analgesics or antiemetics No other investigational drugs during and for 28 days
after study No concurrent drugs that induce or inhibit CYP3A enzyme No concurrent herbal
preparations (e.g., PC-SPES)