NCT00182741

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

September 15, 2005

Last Update Submit

May 1, 2017

Conditions

Prostate Cancer

Keywords

recurrent prostate cancerstage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Interventions

calcitriolDIETARY_SUPPLEMENT
mitoxantrone hydrochlorideDRUG
prednisoneDRUG

Eligibility Criteria

Age18 Years - 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Related Publications (1)

  • 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.

    PMID: 18782306RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

CalcitriolMitoxantronePrednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPregnadienediolsPregnadienesPregnanes

Study Officials

  • Christopher W. Ryan, MD

    OHSU Knight Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 16, 2005

Study Start

September 1, 2004

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

US(1)