Phase II Open-Label Study of Taxoprexin (DHA-Paclitaxel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Hormone-Refractory Prostate Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of the prostate

- Progressive metastatic disease on continuous hormonal therapy (e.g., orchiectomy
or luteinizing hormone-releasing hormone (LHRH) agonist)

- Progressive disease is defined by all of the following:

- Measurable disease or lesions on bone scan

- Increases in prostate-specific antigen (PSA) levels on at least 2
consecutive measurements

- Continued PSA elevation after cessation of prior antiandrogen therapy (4
weeks after flutamide and nilutamide and 8 weeks after bicalutamide)

- PSA level at least 5 ng/mL

- Serum testosterone level less than 50 ng/mL

- Patients who have not undergone prior surgical castration should continue
primary androgen suppression (LHRH agonist)

- No known or clinical evidence of CNS metastasis

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No uncontrolled ventricular arrhythmia

- No myocardial infarction within the past 3 months

- No superior vena cava syndrome

Neurologic:

- No peripheral neuropathy greater than grade 1

- No uncontrolled major seizure disorder

- No spinal cord compression

Other:

- No psychiatric disorder that would preclude informed consent

- No unstable or serious concurrent medical condition

- No concurrent serious infection requiring parenteral therapy

- No other prior or concurrent malignancy except:

- Curatively treated nonmelanoma skin cancer OR

- Other cancer curatively treated with surgery alone that has not recurred for
more than 5 years

- Fertile patients must use effective contraception during and for at least 6 months
after study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent immunotherapy

Chemotherapy:

- No prior taxanes

- Prior mitoxantrone or prednisone for metastatic disease allowed

- At least 28 days since prior chemotherapy and recovered

- No other concurrent chemotherapy

Endocrine therapy:

- See Disease Characteristics

- No concurrent hormonal therapy

Radiotherapy:

- No prior samarium SM 153 lexidronam pentasodium or strontium chloride Sr 89

- Prior external radiotherapy for metastatic disease allowed

- At least 28 days since prior large-field radiotherapy and recovered

- No concurrent radiotherapy, including whole-brain radiotherapy for documented CNS
metastasis

Surgery:

- See Disease Characteristics

- At least 14 days since prior major surgery and recovered

Other:

- No other prior nonhormonal treatment for metastatic disease

- At least 28 days since prior herbal preparations (e.g., PC-SPES) and recovered

- No other concurrent anticancer medications