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Ketoconazole, Dexamethasone, and Hydrocortisone in Treating Patients With Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy

This study has been withdrawn prior to enrollment.
(Withdrawn due to low accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00559481
First received: November 15, 2007
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Prostate Cancer
 Drug: dexamethasone
Drug: ketoconazole
Drug: therapeutic hydrocortisone
Procedure: pharmacological study

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Oral Ketoconazole on the Pharmacokinetics of Oral Dexamethasone and Oral Hydrocortisone in Patients With Androgen Independent Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Pharmacokinetics of oral dexamethasone with and without oral ketoconazole [ Designated as safety issue: No ]
  • Pharmacokinetics of oral hydrocortisone with and without oral ketoconazole [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2007
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To evaluate the pharmacokinetics of oral dexamethasone with and without oral ketoconazole in patients with androgen-independent prostate cancer.
  • To compare the pharmacokinetics of oral hydrocortisone with and without oral ketoconazole in these patients.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral dexamethasone twice daily on days 1-14, oral ketoconazole 3 times daily on days 2-14 and 30-42, and oral hydrocortisone twice daily on days 29-42.
  • Arm II: Patients receive oral hydrocortisone twice daily on days 1-14, oral ketoconazole 3 times daily on days 2-14 and 30-42, and oral dexamethasone twice daily on days 29-42.

In both arms, patients may receive ketoconazole and hydrocortisone as standard salvage therapy off study.

In both arms, patients undergo blood sample collection on days 1, 14, 29, and 42 for pharmacokinetic studies.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559481

Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Donald L. Trump, MD Roswell Park Cancer Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00559481     History of Changes
Other Study ID Numbers: I 93506, RPCI-I-93506
Study First Received: November 15, 2007
Last Updated: January 31, 2013
Health Authority: Unspecified

Keywords provided by Roswell Park Cancer Institute:
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone-17-butyrate
Genital Diseases, Male
Prostatic Diseases
Androgens
Dexamethasone acetate
Cortisol succinate
Hydrocortisone acetate
Dexamethasone
Hydrocortisone
 Dexamethasone 21-phosphate
BB 1101
Ketoconazole
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on May 23, 2013