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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
calcitriol
mitoxantrone hydrochloride
prednisone
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer Androgen-independent disease, defined as disease progression while on standard hormonal management, including antiandrogen withdrawal Patients must continue primary hormonal therapy during study treatment Regional or distant metastases Prostate-specific antigen > 5 ng/mL No brain metastases PATIENT CHARACTERISTICS: Age 18 to 100 Performance status ECOG 0-3 Life expectancy Not specified Hematopoietic Adequate hematologic function Hepatic Adequate hepatic function Renal Adequate renal function No calcium-salt kidney stones within the past 5 years No hypercalcemia Cardiovascular Adequate cardiac function No significant cardiac disease No atrial fibrillation Other Fertile patients must use effective barrier contraception during and for 2 months after completion of study treatment No other serious medical illness No other active malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy More than 28 days since prior biologic therapy Chemotherapy No prior chemotherapy Endocrine therapy See Disease Characteristics Radiotherapy No prior strontium chloride Sr 89 More than 28 days since prior radiotherapy More than 56 days since prior samarium Sm 153 lexidronam pentasodium Surgery Prior prostatectomy and/or orchiectomy allowed Other More than 28 days since prior investigational therapy

Sites / Locations

  • Cancer Institute at Oregon Health and Science University

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 15, 2005
Last Updated
May 1, 2017
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00182741
Brief Title
Calcitriol, Mitoxantrone, and Prednisone in Treating Patients With Metastatic Prostate Cancer
Official Title
Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
recurrent prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
calcitriol
Intervention Type
Drug
Intervention Name(s)
mitoxantrone hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisone
Primary Outcome Measure Information:
Title
Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days
Secondary Outcome Measure Information:
Title
Toxicity as measured by Common Toxicity Criteria v3.0
Title
Frozen plasma and serum samples for correlative biomarker analysis collected every 21 days
Title
Confirmed PSA reduction > 75% measured every 21 days
Title
PSA normalization (< 4 ng/mL) measured every 21 days
Title
Response to measurable disease as measured by RECIST criteria every 9 weeks
Title
Analgesic response as measured by McGill-Melzack Pain Questionnaire every 21 days
Title
Analgesic medication use decreased by ≥ 50% without an increase in pain for 2 consecutive evaluations at least 3 weeks apart
Title
Palliative response as measured by McGill-Melzack Pain Questionnaire every 21 days
Title
Quality of life as measured by EORTC core questionnaire Quality of Life-C30 every 21 days
Title
Time to palliative-progression as measured by McGill-Melzack Pain Questionnaire every 21 days
Title
Time to PSA progression measured every 21 days
Title
Time to progression in measurable or evaluable disease as measured by whole body scan and/or CT or MRI scan every 9-12 weeks
Title
Time to death assessed every 6 months after completion of study treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer Androgen-independent disease, defined as disease progression while on standard hormonal management, including antiandrogen withdrawal Patients must continue primary hormonal therapy during study treatment Regional or distant metastases Prostate-specific antigen > 5 ng/mL No brain metastases PATIENT CHARACTERISTICS: Age 18 to 100 Performance status ECOG 0-3 Life expectancy Not specified Hematopoietic Adequate hematologic function Hepatic Adequate hepatic function Renal Adequate renal function No calcium-salt kidney stones within the past 5 years No hypercalcemia Cardiovascular Adequate cardiac function No significant cardiac disease No atrial fibrillation Other Fertile patients must use effective barrier contraception during and for 2 months after completion of study treatment No other serious medical illness No other active malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy More than 28 days since prior biologic therapy Chemotherapy No prior chemotherapy Endocrine therapy See Disease Characteristics Radiotherapy No prior strontium chloride Sr 89 More than 28 days since prior radiotherapy More than 56 days since prior samarium Sm 153 lexidronam pentasodium Surgery Prior prostatectomy and/or orchiectomy allowed Other More than 28 days since prior investigational therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher W. Ryan, MD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Institute at Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18782306
Citation
Chan JS, Beer TM, Quinn DI, Pinski JK, Garzotto M, Sokoloff M, Dehaze DR, Ryan CW. A phase II study of high-dose calcitriol combined with mitoxantrone and prednisone for androgen-independent prostate cancer. BJU Int. 2008 Dec;102(11):1601-6. doi: 10.1111/j.1464-410X.2008.08017.x. Epub 2008 Sep 8.
Results Reference
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Calcitriol, Mitoxantrone, and Prednisone in Treating Patients With Metastatic Prostate Cancer

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