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

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00182741
• Lead Sponsor: OHSU Knight Cancer Institute

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.

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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-16
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cancer Institute at Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States