Docetaxel and Prednisone With/Out OGX-011 in Recurrent or Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the prostate Metastatic or locally recurrent disease Not curable with standard therapy Systemic chemotherapy is indicated, due to disease progression while receiving androgen-ablative therapy (i.e., hormone-refractory disease) Disease progression is defined as development of new metastatic lesions OR ≥ 2 consecutive rises in prostate-specific antigen (PSA) over a reference value Androgen ablative therapy must have included either medical or surgical castration Castrate level of testosterone (≤ 1.7 nmol/L) required if treated with medical androgen ablation Patients with documented disease progression while on peripheral antiandrogens must also have documented PSA progression after stopping antiandrogens PSA ≥ 5 ng/mL No known CNS metastases PATIENT CHARACTERISTICS: Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 No known bleeding disorder Hepatic PT and PTT or INR normal Bilirubin normal AST and ALT ≤ 1.5 times upper limit of normal (ULN) Renal Creatinine ≤ 1.5 times ULN Cardiovascular No significant cardiac dysfunction Other Fertile patients must use effective contraception No pre-existing peripheral neuropathy ≥ grade 2 No active, uncontrolled infection No significant neurological disorder that would preclude study compliance No history of other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy except estramustine and recovered No other concurrent chemotherapy Endocrine therapy See Disease Characteristics At least 4 weeks since prior antiandrogens (6 weeks for bicalutamide) Luteinizing hormone-releasing hormone (LHRH) agonist therapy must be continued* or restarted* during study treatment to maintain castrate levels of testosterone NOTE: *For patients receiving LHRH agonist therapy prior to study entry Radiotherapy At least 4 weeks since prior external beam radiotherapy except low-dose, nonmyelosuppressive radiotherapy Must have had less than 25% of marrow irradiated No prior strontium chloride Sr 89 No concurrent radiotherapy except low-dose, nonmyelosuppressive, palliative radiotherapy Surgery At least 2 weeks since prior major surgery Other At least 4 weeks since prior investigational agent At least 4 weeks since prior anticancer therapy No concurrent therapeutic anticoagulants except low-dose oral anticoagulants (i.e., 1 mg warfarin) or low molecular weight heparin No other concurrent investigational agents No other concurrent cytotoxic therapy
Sites / Locations
- University of Washington
- Tom Baker Cancer Centre
- Cross Cancer Institute
- QEII Health Sciences Center
- Juravinski Cancer Centre at Hamilton Health Sciences
- BCCA - Cancer Centre for the Southern Interior
- London Regional Cancer Program
- CHUM - Hopital Notre-Dame
- Atlantic Health Sciences Corporation
- Odette Cancer Centre
- Univ. Health Network-Princess Margaret Hospital
- BCCA - Vancouver Cancer Centre
- CancerCare Manitoba
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
OGX011, Docetaxel and Prednisone
Docetaxel plus prednisone