A Phase I/II Study of Adjuvant Prostate Irradiation and Ixabepilone For High Risk Prostate Cancer Post-Prostatectomy
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Maximum-tolerated dose (phase I)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ixabepilone
Adjuvant therapy
Intervention: ixabepilone (Drug)
ixabepilone
Adjuvant therapy
Intervention: adjuvant therapy (Procedure)
ixabepilone
Adjuvant therapy
Intervention: intensity-modulated radiation therapy (Radiation)
Outcomes
Primary Outcomes
Maximum-tolerated dose (phase I)
Time Frame: 3 years
Maximum-tolerated dose (phase I)
Dose-limiting toxicity (phase I)
Time Frame: 3 years
Dose-limiting toxicity (phase I)
Freedom from progression for 3 years (phase II)
Time Frame: 3 years
Freedom from progression for 3 years (phase II)
Secondary Outcomes
- Time to biochemical, local and distant failure (phase II)(3 years)
- Disease-specific survival (phase II)(3 years)
- Adverse events as assessed by NCI CTCAE v. 4.0(3 years)
- Overall survival rate (phase II)(3 years)