Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate
• Stage IV disease
• Radiographic evidence of regional or distant metastases
• Evidence of disease progression (by PSA and/or imaging studies) despite standard hormonal therapy and after exposure to docetaxel-containing chemotherapy, as evidenced by any of the following:
• Measurable or evaluable disease progression, defined as the appearance of new lesion(s) or unequivocal increase in previously existing lesions or masses
• Disease progression by PSA*, defined by 1 of the following:
• 3 consecutively rising PSA with the second PSA taken ≥ 1 week after the first PSA
• 2 consecutively rising PSA with a fourth PSA > the second PSA NOTE: *The last required PSA must be after the required antiandrogen washout period for patients who have been on antiandrogen therapy
• Must have received prior therapy with at least two 3-weekly doses or six weekly doses of docetaxel
• Patients may have discontinued therapy due to progression, intolerance, completion of planned therapy, or other reasons
• Prior treatment with combinations of docetaxel with estramustine phosphate sodium or noncytotoxic agents (biologic agents) allowed
• Serum testosterone < 50 ng/dL (unless surgically castrate)
• Patients must continue androgen deprivation with a luteinizing hormone-releasing hormone agonist if they have not undergone orchiectomy
• No known or suspected brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Life expectancy > 3 months
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• AST and ALT ≤ 2.5 times ULN
• No other active malignancy except adequately treated nonmelanoma skin cancer or other noninvasive or in situ neoplasm
• No other significant active medical illness or infection that would preclude study compliance
• No significant cardiovascular illness, including any of the following:
• NYHA class III or IV congestive heart failure
• Unstable angina
• Myocardial infarction within the past 6 months
• Acute deep venous thrombosis
• Acute pulmonary embolism
• No significant peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 6 weeks since prior antiandrogen therapy (4 weeks for flutamide)
• No current evidence of an antiandrogen withdrawal response
• More than 4 weeks since prior radiotherapy
• More than 8 weeks since prior radiopharmaceutical therapy (strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium)
• No prior paclitaxel
• No other concurrent cytotoxic agents
• No other concurrent chemotherapy or biologic response modifiers
• No concurrent supplements known or suspected to contain supplemental estrogens