Evaluation of Safety and Feasibility of OGX-011 in Combination With 2nd-line Chemotherapy in Patients With HRPC

Inclusion Criteria

• •1. Age ≥ 18 years
• •2. Histologic diagnosis of adenocarcinoma of the prostate.
• •3. Metastatic disease on chest X-ray, bone scan, or computed tomography (CT) scan.
• •4. Failed after receiving a minimum of two cycles of a docetaxel based first line therapy regimen. Failure is defined as disease progression within 6 months of discontinuing first line docetaxel therapy. Disease progression is defined as one or more of the following:
• •* Progressive measurable (target) disease (by Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria): at least a 20% increase in the sum of the longest diameters of measurable lesions (organ masses or lymph nodes) over the smallest sum observed (baseline or nadir) or the appearance of one or more new lesions as assessed by CT scan or chest X-ray.
• •* Bone scan progression: one or more new lesions on bone scan while on or following docetaxel treatment.
• •* Increasing serum PSA level: rise in PSA on three consecutive measurements obtained at least one week apart. If the third PSA value is less than the second, an additional fourth test to confirm a rising PSA will be acceptable.
• •5. Baseline laboratory values as stated below:
• •* Creatinine ≤ 1.5 x upper limit of normal (ULN)
• •* Bilirubin ≤ 1.1 x ULN (unless elevated secondary to conditions such as Gilbert's disease)
• •* SGOT (AST) ≤ 1.5 x ULN
• •* Castrate serum testosterone level (\< 50 ng/mL-or-\< 1.7 mmol/L).
• •6. If not treated with bilateral orchiectomy, patients must be willing to continue luteinizing hormone releasing hormone analogues throughout the study.
• •7. Adequate bone marrow function defined as absolute neutrophil count (ANC) ≥ 1.5 x 10\^9 cells/L and platelet count ≥ 100 x 10\^9/L.
• •8. Karnofsky score ≥ 60
• •9. Received no other chemotherapy, radioisotope therapy, strontium 89, or samarium 153. (Prior radiotherapy and steroids following first line docetaxel therapy are allowed.)
• •10. Received no more than one prior biological response modifier therapy following first line docetaxel therapy.
• •11. At least 21 days since completing the last dose of docetaxel, biological response modifier, and/or radiotherapy. (Exception for radiotherapy: at least 7 days since completing a single fraction of ≤ 800 cGy to a restricted field.)
• •12. Has recovered from all therapy related toxicity to ≤ grade 2, (except alopecia and anemia.)
• •13. Willing and able to give informed consent and follow protocol requirements.