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

Sponsor:	Roswell Park Cancer Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00559481

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:	Treatment, Randomized, Open Label
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:

Further study details as provided by National Cancer Institute (NCI):

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 ]

Estimated Enrollment:	12
Study Start Date:	October 2007
Estimated Primary Completion Date:	January 2010 (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

Locations

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators

Roswell Park Cancer Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Donald L. Trump, MD

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000574126, RPCI-I-93506
Study First Received:	November 15, 2007
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00559481 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent prostate cancer

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Anti-Infective Agents
Hydrocortisone
Prostatic Diseases
Genital Neoplasms, Male
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Urogenital Neoplasms
Hormones
Neoplasms by Site
Antifungal Agents
Therapeutic Uses

Dexamethasone acetate
Antineoplastic Agents, Hormonal
Cortisol succinate
Gastrointestinal Agents
Genital Diseases, Male
Ketoconazole
Glucocorticoids
Pharmacologic Actions
Neoplasms
Autonomic Agents
Hydrocortisone acetate
Peripheral Nervous System Agents
Prostatic Neoplasms
Central Nervous System Agents
Androgens

ClinicalTrials.gov processed this record on February 08, 2010