Ketoconazole With or Without Alendronate Sodium in Treating Patients With

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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. PROJECTED ACCRUAL: A total of 72 patients (36 per arm) will be accrued for this study within 3 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00019695
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Terminated
Phase	Phase 2
Start date	March 1999
Completion date	March 2005

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Ketoconazole With or Without Alendronate Sodium in Treating Patients With Metastatic Prostate Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms