Radiation Therapy and Ixabepilone in Treating Patients With High-Risk Stage III Prostate Cancer After Surgery
|ClinicalTrials.gov Identifier: NCT01079793|
Recruitment Status : Unknown
Verified May 2010 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : March 3, 2010
Last Update Posted : June 14, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: ixabepilone Procedure: adjuvant therapy Radiation: intensity-modulated radiation therapy||Phase 1 Phase 2|
- 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)
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Adjuvant Prostate Irradiation and Ixabepilone For High Risk Prostate Cancer Post-Prostatectomy|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||March 2012|
- Dose-limiting toxicity (phase I)
- Maximum-tolerated dose (phase I)
- Freedom from progression for 3 years (phase II)
- Time to biochemical, local and distant failure (phase II)
- Disease-specific survival (phase II)
- Overall survival rate (phase II)
- Adverse events as assessed by NCI CTCAE v. 4.0
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01079793
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097|
|OverallOfficial:||Arlene Thomas||Simmons Cancer Center|
|Principal Investigator:||David A. Pistenmaa, MD||Simmons Cancer Center|