Radiation Therapy & Ixabepilone in Treating Patients With High-Risk Stage

Status Withdrawn

Clinical Trial Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Ixabepilone may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy with chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase I/II trial is studying the side effects and best dose of ixabepilone when given together with radiation therapy to see how well it works in treating patients with high-risk stage III prostate cancer after surgery.

Clinical Trial Description

OBJECTIVES:

Primary

- To determine the maximum-tolerated dose and dose-limiting toxicity of ixabepilone in combination with concurrent intensity-modulated radiation therapy in patients with high-risk prostate cancer after prostatectomy. (Phase I)

- To determine the toxicity profile of this regimen in these patients. (Phase I)

Secondary

- To assess freedom from progression in patients treated with this regimen. (Phase II)

- To assess biochemical failure, local failure, and distant failure in patients treated with this regimen. (Phase II)

- To assess disease-specific survival and overall survival of patients treated with this regimen. (Phase II)

- To evaluate acute and late toxicity of this regimen in these patients.

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

Patients undergo adjuvant intensity-modulated radiation therapy once daily, 5 days a week, for 7-9 weeks. Patients also receive concurrent ixabepilone IV over 1 hour on days 1 and 8. Treatment with ixabepilone repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 3 years, and then annually for 6 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01079793
Study type	Interventional
Source	University of Texas Southwestern Medical Center
Contact
Status	Withdrawn
Phase	Phase 1/Phase 2
Start date	May 26, 2010
Completion date	October 17, 2011

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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.

Radiation Therapy and Ixabepilone in Treating Patients With High-Risk Stage III Prostate Cancer After Surgery

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms