Radiation Therapy and Ixabepilone in Treating Patients With High-Risk Stage III Prostate Cancer After Surgery
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT01079793
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ixabepilone ixabepilone Adjuvant therapy ixabepilone adjuvant therapy Adjuvant therapy ixabepilone intensity-modulated radiation therapy Adjuvant therapy
- Primary Outcome Measures
Name Time Method Maximum-tolerated dose (phase I) 3 years Maximum-tolerated dose (phase I)
Dose-limiting toxicity (phase I) 3 years Dose-limiting toxicity (phase I)
Freedom from progression for 3 years (phase II) 3 years Freedom from progression for 3 years (phase II)
- Secondary Outcome Measures
Name Time Method Time to biochemical, local and distant failure (phase II) 3 years Time to biochemical, local and distant failure (phase II)
Disease-specific survival (phase II) 3 years Disease-specific survival (phase II)
Adverse events as assessed by NCI CTCAE v. 4.0 3 years Adverse events as assessed by NCI CTCAE v. 4.0
Overall survival rate (phase II) 3 years Overall survival rate (phase II)
Trial Locations
- Locations (1)
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States