Radiation Therapy and Ixabepilone in Treating Patients With High-Risk Stage III Prostate Cancer After Surgery
Recruitment status was Recruiting
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.
Procedure: adjuvant therapy
Radiation: intensity-modulated radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Adjuvant Prostate Irradiation and Ixabepilone For High Risk Prostate Cancer Post-Prostatectomy|
- Dose-limiting toxicity (phase I) [ Designated as safety issue: Yes ]
- Maximum-tolerated dose (phase I) [ Designated as safety issue: Yes ]
- Freedom from progression for 3 years (phase II) [ Designated as safety issue: No ]
- Time to biochemical, local and distant failure (phase II) [ Designated as safety issue: No ]
- Disease-specific survival (phase II) [ Designated as safety issue: No ]
- Overall survival rate (phase II) [ Designated as safety issue: No ]
- Adverse events as assessed by NCI CTCAE v. 4.0 [ Designated as safety issue: Yes ]
|Study Start Date:||May 2010|
|Estimated Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
- 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.
|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|
|Investigator:||Arlene Thomas||Simmons Cancer Center|
|Principal Investigator:||David A. Pistenmaa, MD||Simmons Cancer Center|