Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)
- Determine the prostate-specific antigen (PSA) response rate, defined as the fraction of
patients with 50% reduction in PSA level over 3 weeks' time, in patients with
androgen-independent metastatic prostate cancer treated with high-dose pulse
calcitriol, mitoxantrone, and prednisone.
- Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral high dose pulse calcitriol on day 1, mitoxantrone IV on day 2, and
oral prednisone on days 1-21. Treatment repeats every 21 days for up to 12 courses in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days
Christopher W. Ryan, MD
OHSU Knight Cancer Institute
United States: Federal Government
|Cancer Institute at Oregon Health and Science University||Portland, Oregon 97201-3098|