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

Inclusion Criteria

• •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)