SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy

DISEASE CHARACTERISTICS:

• Histologically confirmed prostate cancer not amenable to curative treatment with surgery or radiotherapy

• Progressive disease defined by 1 of the following criteria:

  • New bone scan lesions
  • New or progressive radiologic lesions
  • Sequential increases in PSA on at least 2 successive measurements no less than 2 weeks apart of at least 50% above nadir on prior therapy provided absolute value at time of enrollment is at least 5 ng/mL

• Progressive disease, as defined above, despite adequate hormonal therapy defined by all of the following:

  • Continued treatment with an LHRH agonist or prior orchiectomy
  • Sequential or concurrent treatment with an antiandrogen (e.g., flutamide, nilutamide, or bicalutamide)
  • Trial of antiandrogen withdrawal at least 4 weeks prior to study

• CNS metastasis allowed if:

  • Previously treated
  • Neurologically stable
  • Oral or intravenous steroids or anticonvulsants not required

  • Brain scan (CT or MRI) within the past 2 weeks shows no active or residual disease

    • Negative brain scan required if neurologic signs or symptoms suggestive of CNS metastasis

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm^3
• Platelet count at least 75,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• Transaminases no greater than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 2.0 mg/dL OR
• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No uncompensated coronary artery disease
• No history of myocardial infarction or severe unstable angina within the past 6 months
• No severe peripheral vascular disease associated with diabetes mellitus
• No deep venous or arterial thrombosis within the past 3 months

Pulmonary:

• No pulmonary embolism within the past 3 months

Other:

• Not pregnant
• Fertile patients must use effective contraception
• No significant uncontrolled underlying medical or psychiatric illness
• No serious active infection
• No other prior or concurrent malignancy except nonmelanoma skin cancer unless completed therapy and considered to be at less than 30% risk of relapse
• No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior systemic chemotherapy
• No other concurrent chemotherapy
• No other concurrent investigational antineoplastic drugs

Endocrine therapy:

• See Disease Characteristics

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy
• No concurrent radiotherapy

Surgery:

• See Disease Characteristics
• At least 4 weeks since prior major surgery