Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT00471718
Brief 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.
Detailed 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:
NCT00471718
Study Brief:
Protocol Section:
NCT00471718