Phase II Study of Weekly Paclitaxel and Bryostatin-1 in Hormone Refractory Prostate Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic adenocarcinoma of the prostate that failed first-
or second-line hormonal therapy (e.g., gonadal androgen suppression [orchiectomy or
luteinizing hormone-releasing hormone] with or without antiandrogens)

- Failure on hormonal therapy is defined by 1 of the following criteria:

- Biochemical progression (after withdrawal of antiandrogens), documented by
3 rising PSA values, each value measured at least 2 weeks apart, with the
last measurement being at least 25% of the nadir achieved while on hormonal
therapy and with an increase in the absolute value by at least 5 ng/mL

- Measurable disease progression, defined by an increase in the sum of the
products of the perpendicular diameters of any measurable lesion(s) by at
least 25%

- Bone only progression allowed only with concurrent biochemical progression

- Castrate levels of testosterone (no greater than 50 ng/dL)

- No clinical signs/symptoms suggesting CNS metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- More than 6 months

Hematopoietic

- WBC at least 3,000/mm^3

- Absolute granulocyte 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)

- AST/ALT no greater than 2.5 times ULN

Renal

- Creatinine no greater than 1.5 times ULN

- Calcium no greater than ULN

Cardiovascular

- No uncontrolled or severe cardiovascular disease

- No myocardial infarction within the past 6 months

- No congestive heart failure

- No angina pectoris

- No active thromboembolic events within the past 3 months (e.g., deep venous
thrombosis or cerebrovascular accident)

Other

- No other serious medical or psychiatric illness

- No active infection

- No dementia or significantly altered mental status

- No prior or concurrent grade 1 or greater peripheral neuropathy

- No other prior or concurrent malignancy within the past 5 years except curatively
treated nonmelanoma skin cancer

- HIV negative

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Chemotherapy

- No prior chemotherapy (including paclitaxel)

Endocrine therapy

- At least 4 weeks since prior steroids or megestrol

Radiotherapy

- At least 4 weeks since prior radiotherapy to bone lesions

Other

- No other concurrent investigational therapy