ABT-751 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

Prostate Cancer Clinical Trial

Official title: A Phase1/2 Trial of ABT-751 in Patients With Advanced, Androgen-Independent Prostate Cancer

Status Terminated

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I/II trial is studying the side effects and best dose of ABT-751 and to see how well it works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.

Clinical Trial Description

OBJECTIVES:

Primary

• Evaluate the safety and efficacy of ABT-751 in patients with androgen-independent, hormone-refractory metastatic prostate cancer and determine the maximum tolerated dose (MTD) and optimal phase II dose of this drug in these patients.

Secondary

• Determine the objective response rate (partial and complete response) in patients with measurable disease treated with this drug.

• Evaluate the effect of this drug on prostate-specific antigen (PSA) response in patients with nonmeasurable disease.

• Determine the time to tumor progression in patients treated with this drug.

• Determine survival of patients treated with this drug.

• Determine the toxicity of this drug in these patients.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

• Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of ABT-751 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 50 additional patients may be treated at the recommended phase II dose (RPTD) which is the dose level at the maximally administered dose.

• Phase II: Patients receive ABT-751 at the MTD determined in phase I. After completion of study treatment, patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study. ;

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00471718
• Study type: Interventional
• Source: Vanderbilt-Ingram Cancer Center
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: January 2004
• Completion date: August 2009