OGX-011 and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Solid Tumors

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed solid tumors that have been shown to overexpress clusterin, including but not limited to, any of the following:

  • Prostate cancer
  • Renal cell carcinoma
  • Non-small cell lung cancer
  • Bladder cancer
  • Breast cancer
  • Ovarian cancer
• Metastatic or locally recurrent disease

• Refractory to standard curative therapy or no standard curative therapy exists

  • Patients with prostate cancer must be hormone refractory (i.e., have documented evidence of progression while receiving androgen ablative therapy)

• Measurable or nonmeasurable disease

  • Measurable disease defined as measurable lesion ≥ 20 mm by x-ray, physical exam, or nonspiral CT scan or ≥ 10 mm by spiral CT scan
• No documented CNS metastases
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified
• ECOG performance status 0-2
• Life expectancy ≥ 12 weeks
• Absolute granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin normal
• Creatinine ≤ 2 times upper limit of normal (ULN)
• AST and ALT ≤ 1.5 times ULN
• PT/INR and PTT normal
• No uncontrolled pain
• No known bleeding disorder
• No history of serious allergic reaction to taxane (paclitaxel or docetaxel)
• No preexisting peripheral neuropathy ≥ grade 2
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

• No other serious illness or medical conditions that would preclude study compliance, including any of the following:

  • Active uncontrolled infection
  • Significant cardiac dysfunction
• No significant neurological disorder that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

• No prior strontium chloride Sr 89
• No more than 2 prior chemotherapy regimens, including adjuvant or neoadjuvant chemotherapy (for patients assigned to schedule B [docetaxel once every 3 weeks])
• More than 4 weeks since prior chemotherapy and recovered
• At least 4 weeks since prior antiandrogens
• More than 4 weeks since prior external-beam radiotherapy, except low-dose nonmyelosuppressive radiotherapy
• No prior radiotherapy to ≥ 30% of marrow-bearing areas (for patients assigned to schedule B [docetaxel once every 3 weeks])
• At least 28 days since prior new anticancer therapy
• At least 28 days since prior and no other concurrent investigational agents
• No concurrent radiotherapy, except low-dose nonmyelosuppressive radiotherapy
• No other concurrent cytotoxic therapy
• Concurrent luteinizing hormone-releasing hormone agonist allowed (if already initiated in patients with prostate cancer)
• No concurrent anticoagulant therapy (i.e., heparin, warfarin)