Ketoconazole With or Without Alendronate Sodium in Treating Patients With Metastatic Prostate Cancer
RATIONALE: Ketoconazole may suppress the production of hormones and may interfere in the growth of prostate cancer cells. Alendronate sodium may be effective in preventing bone metastases and bone pain associated with prostate cancer. It is not known if ketoconazole is more effective with or without alendronate sodium.
PURPOSE: Randomized phase II trial to study the effectiveness of ketoconazole with or without alendronate sodium in treating patients who have metastatic prostate cancer.
|Stage IV Prostate Cancer Bone Metastases Adenocarcinoma of the Prostate Recurrent Prostate Cancer||Drug: alendronate sodium Drug: ketoconazole||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Randomized Study of High-Dose Ketoconazole With or Without Alendronate Sodium in Patients With Androgen-Independent Metastastic Adenocarinoma of the Prostate|
|Study Start Date:||March 1999|
|Study Completion Date:||March 2005|
OBJECTIVES: I. Determine whether there is any evidence that ketoconazole plus alendronate sodium produces acceptable disease responses as compared with ketoconazole alone in patients with androgen-independent metastatic adenocarcinoma of the prostate.
II. Characterize the pharmacokinetics/pharmacodynamics and assess the bone marrow concentrations of both agents.
III. Assess matrix metalloproteinase (MMP) inhibition potential of alendronate sodium by monitoring markers of angiogenesis, MMP breakdown, and changes in hydroxyproline.
PROTOCOL OUTLINE: This is a randomized, open-label study. Patients are randomized to one of two treatment arms.
Arm I: Patients receive a single oral dose of ketoconazole on day 1. Patients begin taking ketoconazole 3 times per day on day 8.
Arm II: Patients receive a single oral dose of alendronate sodium on day 1 and a single oral dose of ketoconazole on day 3. Patients begin taking alendronate sodium once every morning and ketoconazole 3 times per day on day 8.
Treatment continues on both arms in the absence of unacceptable toxicity or disease progression. Patients who experience a clinical complete remission (CR) receive treatment for an additional 60 days beyond documentation of a clinical CR.
Patients are followed every 2 months.
A total of 72 patients (36 per arm) will be accrued for this study within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019695
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||William D. Figg||National Cancer Institute (NCI)|