NCT00559481

Brief Summary

RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving ketoconazole together with dexamethasone and hydrocortisone may help doctors learn more about how these drugs are used by the body. PURPOSE: This randomized clinical trial is studying how ketoconazole, dexamethasone, and hydrocortisone act in the body of patients with prostate cancer that did not respond to androgen-deprivation therapy.

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Last Updated

February 1, 2013

Status Verified

January 1, 2013

Enrollment Period

11 months

First QC Date

November 15, 2007

Last Update Submit

January 31, 2013

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics of oral dexamethasone with and without oral ketoconazole

  • Pharmacokinetics of oral hydrocortisone with and without oral ketoconazole

Interventions

dexamethasoneDRUG
ketoconazoleDRUG
therapeutic hydrocortisoneDRUG
pharmacological studyPROCEDURE

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Confirmed diagnosis of prostate cancer * Must have failed standard androgen-deprivation therapy * Evidence of rising PSA PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Creatinine ≤ 2.0 mg/dL * AST and ALT \< 4 times upper limit of normal * Bilirubin \< 2.0 mg/dL * No active congestive heart failure * No allergy to ketoconazole, dexamethasone, hydrocortisone, or to one of the components of dexamethasone, hydrocortisone, or ketoconazole * No active infection * No uncontrolled glaucoma * No active peptic ulcer disease * No uncontrolled diabetes mellitus * Fertile patients must use effective contraception during and for 3 months after completion of study therapy PRIOR CONCURRENT THERAPY: * More than 2 weeks since prior and no concurrent drugs known to interact with study treatment

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

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

DexamethasoneKetoconazoleHydrocortisone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnenedionesPregnenes11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Donald L. Trump, MD

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 16, 2007

Study Start

October 1, 2007

Primary Completion

September 1, 2008

Last Updated

February 1, 2013

Record last verified: 2013-01