A Phase II Study of GTI-2040 in Combination With Docetaxel and Prednisone in Hormone-Refractory Prostate Cancer
- Determine the efficacy of GTI-2040, docetaxel, and prednisone, in terms of
prostate-specific antigen (PSA) response rate, in patients with hormone-refractory
- 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
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 3.6-9.5
Masking: Open Label, Primary Purpose: Treatment
PSA response rate
Malcolm J. Moore, MD
Princess Margaret Hospital, Canada
United States: Federal Government