Know Cancer

or
forgot password

Effect of Oral Ketoconazole on the Pharmacokinetics of Oral Dexamethasone and Oral Hydrocortisone in Patients With Androgen Independent Prostate Cancer


N/A
N/A
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Effect of Oral Ketoconazole on the Pharmacokinetics of Oral Dexamethasone and Oral Hydrocortisone in Patients With Androgen Independent Prostate Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetics of oral dexamethasone with and without oral ketoconazole

Safety Issue:

No

Principal Investigator

Donald L. Trump, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

Unspecified

Study ID:

I 93506

NCT ID:

NCT00559481

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location