NCT00010231

Brief Summary

RATIONALE: Combining calcitriol with dexamethasone may increase the effectiveness of therapy by making cancer cells more sensitive to dexamethasone. PURPOSE: Phase I trial to study the effectiveness of calcitriol combined with dexamethasone in treating patients who have prostate cancer that has not responded to previous hormone therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 prostate-cancer

Timeline
Completed

Started Jun 1999

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

June 1, 1999

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 6, 2003

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

3.2 years

First QC Date

February 2, 2001

Last Update Submit

March 27, 2015

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage III prostate cancerstage IV prostate cancerrecurrent prostate cancer

Outcome Measures

Primary Outcomes (2)

  • MTD of calcitriol (oral) administered for 3 days (Monday, Tuesday, Wednesday -MTW) weekly in men with hormone-refractory prostate cancer

    1 year

  • MTD of calcitriol (oral, MTW weekly + dexamethasone (oral, Sunday, Monday, Tuesday, Wednesday - SMTW) in men with hormone refractory prostate cancer

    1 year

Secondary Outcomes (3)

  • whether dexamethasone permits the administration of calcitriol without the development of hypercalcemia in patients who developed hypercalcemia while receiving calcitriol alone

    1 year

  • pharmacokinetics of calcitriol when given as a single agent and following 3 days of dexamethasone

    1 year

  • effects of calcitriol +/- dexamethasone on serum PTH, urinary calcium and MAPK activity and VDR expression in serum, urine and PBMs , respectively, in this patient population

    1 year

Interventions

calcitriolDIETARY_SUPPLEMENT
dexamethasoneDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate with progressing regional or metastatic disease despite primary hormonal therapy (bilateral orchiectomy, estrogen, or luteinizing hormone-releasing hormone (LHRH) therapy with or without simultaneous antiandrogen) * Documented new lesions or rising PSA (at least 50% increase on 3 measurements more than 2 weeks apart) after prior antiandrogen or progestational agent, or other hormonal agent cessation PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC greater than 3,500/mm\^3 * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL * SGOT less than 4 times upper limit of normal Renal: * Creatinine no greater than 1.8 mg/dL Other: * No uncontrolled diabetes mellitus * Fertile patients must use effective double barrier contraception for at least 1 week before, during, and at least 2 weeks after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * Concurrent epoetin alfa for anemia allowed Chemotherapy: * Not specified Endocrine therapy: * See Disease Characteristics * At least 28 days since prior antiandrogens or progestational agents * Concurrent testicular androgen suppression with an LHRH analog (leuprolide or goserelin) allowed in non-orchidectomized patients Radiotherapy: * No concurrent radiotherapy Surgery: * Not specified Other: * No concurrent bisphosphonates

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

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

CalcitriolDexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsPregnadienetriolsPregnadienesPregnanesSteroids, Fluorinated

Study Officials

  • Gurkamal S. Chatta, MD

    University of Pittsburgh

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2001

First Posted

June 6, 2003

Study Start

June 1, 1999

Primary Completion

August 1, 2002

Study Completion

November 1, 2002

Last Updated

March 30, 2015

Record last verified: 2015-03

Locations

US(1)