NCT00182741CompletedPhase 2
Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)
OHSU Knight Cancer Institute2 sites in 1 country19 target enrollmentStarted: September 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- OHSU Knight Cancer Institute
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days
Secondary Outcomes
- Toxicity as measured by Common Toxicity Criteria v3.0
- Confirmed PSA reduction > 75% measured every 21 days
- Time to palliative-progression as measured by McGill-Melzack Pain Questionnaire every 21 days
- Frozen plasma and serum samples for correlative biomarker analysis collected 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 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
Investigators
Christopher Ryan
Principal Investigator
OHSU Knight Cancer Institute
Study Sites (2)
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