NCT00182741

Calcitriol, Mitoxantrone, and Prednisone in Treating Patients With Metastatic Prostate Cancer

Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Calcitriol may cause prostate cancer cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as mitoxantrone and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well giving calcitriol together with mitoxantrone and prednisone works in treating patients with metastatic prostate cancer.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	calcitriol
DRUG	mitoxantrone hydrochloride
DRUG	prednisone

Timeline

• Start date: 2004-09-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2005-09-16
• Last updated: 2017-05-03

Locations

1 site across 1 country: United States