S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

  • Stage IV disease (any T, any N, M1b)

    • Evidence of bone metastases by bone scan or MRI

• Measurable or nonmeasurable disease

  • Soft tissue disease that has been irradiated within the past 2 months is not assessable as measurable disease

• Hormone-refractory disease despite androgen deprivation and antiandrogen withdrawal, as defined by 1 of the following criteria:

  • Prostate-specific antigen (PSA) progression, defined as 3 consecutive rising PSA levels* taken ≥ 1 week apart

    • PSA ≥ 5 ng/mL NOTE: *If the third confirmatory PSA level is < the second level, the patient is considered eligible provided a fourth PSA level is > the second level
  • Progression of measurable disease
  • Progression of nonmeasurable disease by bone scan

• Must have undergone surgical or medical (e.g., luteinizing hormone-releasing hormone [LHRH] agonist [e.g., leuprolide or goserelin] or LHRH antagonist therapy) castration

  • Patients who have undergone medical castration must continue LHRH agonist or antagonist therapy during study treatment
• Must have completed 12 courses of blinding protocol treatment (atrasentan/placebo) AND stopped docetaxel for any reason (including completion of 12 courses) other than progressive disease
• No symptomatic pleural effusion
• No third space fluid accumulation (e.g., ascites)

• No prior or concurrent brain metastases

  • Patients with clinical evidence of brain metastases must have a negative brain CT scan or MRI within the past 8 weeks

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-3* NOTE: For a performance status of 3, the cause must be due to pain secondary to bone metastases

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Fertile patients must use effective contraception
• Able to take oral medication without crushing, dissolving, or chewing tablets
• No major infection
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer in complete remission
• No symptomatic sensory neuropathy ≥ grade 2
• No history of hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
• No other significant, active medical illness that would preclude study treatment or survival

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No more than 1 prior systemic vaccine or biologic therapy

  • At least 4 weeks since prior vaccine or biologic therapy and recovered
• No concurrent biological response modifiers
• No concurrent prophylactic colony-stimulating factors

Chemotherapy

• More than 2 years since prior adjuvant therapy with a single non-taxane-containing cytotoxic regimen
• No prior cytotoxic chemotherapy for metastatic prostate cancer
• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics
• At least 6 weeks since prior bicalutamide or nilutamide AND has subsequent disease progression
• At least 4 weeks since prior flutamide or ketoconazole AND has subsequent disease progression
• Prior or concurrent megestrol for treatment of hot flashes allowed
• No other concurrent corticosteroid or hormonal therapy unless continuing luteinizing hormone-releasing hormone treatment and/or bisphosphonate therapy

Radiotherapy

• See Disease Characteristics
• Prior samarium allowed
• At least 3 weeks since prior radiotherapy and recovered
• No prior radiotherapy to ≥ 30% of the bone marrow
• No prior strontium
• No concurrent radiotherapy

Surgery

• See Disease Characteristics
• At least 3 weeks since prior surgery and recovered

Other

• More than 4 weeks since prior investigational drugs

• Concurrent bisphosphonates allowed provided therapy is started prior to study entry, dose is maintained during the first 12 weeks of study treatment, and patient meets criteria for disease progression

  • No initiation of bisphosphonates during the first 12 weeks of study treatment

• No concurrent herbal medications or food supplements (e.g., PC-SPES, saw palmetto, Hypericum perforatum [St. John's wort])

  • Concurrent daily vitamins and calcium supplements allowed

• At least 14 days since prior and no concurrent administration of any of the following:

  • Antibiotics (e.g., clarithromycin, erythromycin, troleandomycin, rifampin, rifabutin, and rifapentine)
  • Antifungals (e.g., itraconazole, ketoconazole, fluconazole [doses > 200 mg/day], and voriconazole)
  • Antidepressants (e.g., nefazodone and fluvoxamine)
  • Calcium channel blockers (e.g., verapamil, diltiazem)
  • Miscellaneous (e.g., amiodarone [no use within 6 months prior to study entry], grapefruit juice, bitter orange, or modafinil)
  • Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital, and oxcarbazepine)
  • Antibiotics (e.g., rifampin, rifabutin, and rifapentine)