Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University Health Network, Toronto
With
OBJECTIVES: Primary * Determine the efficacy of GTI-2040, docetaxel, and prednisone, in terms of prostate-specific antigen (PSA) response rate, in patients with hormone-refractory prostate cancer. Secondary * Determine objective tumor response in patients treated with this regimen. * Determine the median time to progression in patients treated with this regimen. * Determine the safety and tolerability of this regimen in these patients. * Determine the median duration of PSA response in patients treated with this regimen. * Correlate baseline and post-treatment levels of ribonucleotide reductase activity in tumor biopsies and peripheral blood mononuclear cells and tumoral expression of c-myc, R2 subunit protein, and markers of cellular proliferation and apoptosis with clinical outcomes in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive GTI-2040 IV continuously on days 1-14, docetaxel IV on day 3 of course 1 and on day 1 of subsequent courses, and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 3.6-9.5 months.
Age
18–120
Sex
MALE
Healthy volunteers
Not accepted
