S0354, Anti-IL-6 Chimeric Monoclonal Antibody in Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate

  * Metastatic disease (N1 and/or M1)
* Disease unresponsive or refractory to androgen-deprivation therapy
* Must have received only 1 prior chemotherapy regimen comprising a taxane OR mitoxantrone
* Disease progression as defined by one or more of the following:

  * Progression of measurable disease

    * Prior radiotherapy allowed provided radiotherapy was completed ≥ 2 months ago and lesion progressed since radiotherapy
  * Progression of nonmeasurable disease

    * Prior radiotherapy within the past 2 months allowed, but disease is considered nonmeasurable
  * Rising prostate-specific antigen (PSA) after \> 2 courses of chemotherapy OR within 6 months of last chemotherapy dose

    * Rising PSA defined as at least 2 consecutive rises in PSA to be documented over a reference value (measure 1)
* PSA ≥ 5 ng/mL
* Surgical or medical castration required

  * Castration using luteinizing hormone-releasing hormone agonist (leuprolide acetate or goserelin) or antagonist (abarelix) should not be interrupted
* No history of brain metastases OR currently treated or untreated brain metastases

  * Patients with clinical suspicion of brain metastases must have a brain CT scan or MRI negative for metastatic disease within the past 56 days

PATIENT CHARACTERISTICS:

* Zubrod performance status 0-2
* Fertile patients must use effective contraception
* Absolute granulocyte count ≥ 1,500/mm³ (transfusion independent)
* Platelet count ≥ 100,000/mm³ (transfusion independent)
* Hemoglobin ≥ 9 g/dL (transfusion independent)
* Creatinine clearance ≥ 40 mL/min
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST) ≤ 2 times ULN
* No uncontrolled intercurrent illnesses including, but not limited to, the following:

  * Diabetes mellitus
  * Ongoing or active infection
  * Symptomatic congestive heart failure
  * Unstable angina pectoris
  * Cardiac arrhythmia
* No psychiatric illness or social situation that would preclude study compliance
* No known HIV positivity
* No other prior malignancy except for the following:

  * Adequately treated basal cell or squamous cell skin cancer
  * Adequately treated stage I or II cancer in complete remission
  * Any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 21 days since prior surgery and recovered
* At least 28 days since prior chemotherapy and recovered
* At least 28 days since prior flutamide or ketoconazole
* At least 28 days since prior radiotherapy (to \< 30% of the bone marrow only) and recovered

  * Prior samarium Sm 153 lexidronam pentasodium allowed
  * No prior strontium chloride Sr 89
* At least 42 days since prior bicalutamide or nilutamide
* More than 60 days since prior murine or chimeric proteins or human/murine monoclonal antibody
* Concurrent bisphosphonate therapy allowed provided the following are true:

  * Therapy commenced at least 3 weeks ago
  * Therapy continues for the entire duration of study treatment
* No other concurrent anticancer therapy, including cytotoxic therapy, biologic therapy, radiotherapy, or hormonal therapy (except for luteinizing hormone-releasing hormone agonist or antagonist in patients who have not had an orchiectomy)