Calcitriol, Mitoxantrone, and Prednisone in Treating Patients With Metastatic Prostate Cancer
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.
Dietary Supplement: calcitriol
Drug: mitoxantrone hydrochloride
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)|
- Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days
- Toxicity as measured by Common Toxicity Criteria v3.0
- Frozen plasma and serum samples for correlative biomarker analysis collected every 21 days
- Confirmed PSA reduction > 75% measured every 21 days
- PSA normalization (< 4 ng/mL) measured every 21 days
- Response to measurable disease as measured by RECIST criteria every 9 weeks
- Analgesic response as measured by McGill-Melzack Pain Questionnaire every 21 days
- Analgesic medication use decreased by ≥ 50% without an increase in pain for 2 consecutive evaluations at least 3 weeks apart
- Palliative response as measured by McGill-Melzack Pain Questionnaire every 21 days
- Quality of life as measured by EORTC core questionnaire Quality of Life-C30 every 21 days
- Time to palliative-progression as measured by McGill-Melzack Pain Questionnaire every 21 days
- Time to PSA progression measured every 21 days
- Time to progression in measurable or evaluable disease as measured by whole body scan and/or CT or MRI scan every 9-12 weeks
- Time to death assessed every 6 months after completion of study treatment
|Study Start Date:||September 2004|
|Study Completion Date:||August 2006|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182741
|United States, Oregon|
|Cancer Institute at Oregon Health and Science University|
|Portland, Oregon, United States, 97239-3098|
|Study Chair:||Christopher W. Ryan, MD||OHSU Knight Cancer Institute|