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

A Randomized Phase II Study of OGX-011 in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Hormone Refractory Prostate Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00258388
Enrollment
82
Registered
2005-11-24
Start date
2005-09-28
Completion date
2011-01-18
Last updated
2023-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer

Brief summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. OGX-011 may help docetaxel and prednisone kill more tumor cells by making tumor cells less resistant to the drugs. PURPOSE: This randomized phase II trial is studying how well giving docetaxel and prednisone with or without OGX-011 works in treating patients with recurrent or metastatic prostate cancer that did not respond to previous hormone therapy.

Detailed description

OBJECTIVES: Primary * Determine the efficacy, in terms of prostate-specific antigen response, of docetaxel and prednisone with or without OGX-011 in patients with hormone-refractory locally recurrent or metastatic prostate cancer. Secondary * Determine the objective response rate and duration in patients treated with these regimens. * Determine the safety and toxic effects of these regimens in these patients. * Determine the overall and progression-free survival of patients treated with these regimens. OUTLINE: This is a multicenter, randomized, open-label study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive a loading dose of OGX-011 IV over 2 hours on days -7, -5, and -3. Patients then receive OGX-011 IV over 2 hours on days 1, 8, and 15, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Interventions

640mg IV for 2 hours - Cycle 1: Days -7, -5, -3, 1, 8, 15 (4 week cycle) Subsequent cycles: weekly on days 1, 8, 15 (3 week cycles)

DRUGdocetaxel

75mg/m2 IV for 1 hour - Day 1 every 3 weeks (3 week cycles)

DRUGprednisone

5mg PO BID

Sponsors

NCIC Clinical Trials Group
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Prostate-specific antigen (PSA) response measured by Bubley criteria at completion of study2 years

Secondary

MeasureTime frame
Toxicity2 years
Time to treatment failure2 years

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026