Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-27 @ 3:01 AM
Study NCT ID:
NCT01079793
Status:
WITHDRAWN
Last Update Posted:
2020-08-20
First Post:
2010-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Therapy and Ixabepilone in Treating Patients With High-Risk Stage III Prostate Cancer After Surgery
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
A Phase I/II Study of Adjuvant Prostate Irradiation and Ixabepilone For High Risk Prostate Cancer Post-Prostatectomy
Status:
WITHDRAWN
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Overlapping study, PI preferred to enroll in alternate trial.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CDR0000666842 | REGISTRY | PDQ (Physician Data Query) | View |