A Phase II Trial of SU5416 (NSC# 686819) in Patients With Hormone Refractory Prostate Cancer

Inclusion Criteria

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