Radiation Therapy and Ixabepilone in Treating Patients With High-Risk Stage III Prostate Cancer After Surgery
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|ClinicalTrials.gov Identifier: NCT01079793|
Recruitment Status : Withdrawn (Overlapping study, PI preferred to enroll in alternate trial.)
First Posted : March 3, 2010
Last Update Posted : August 20, 2020
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)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Adjuvant Prostate Irradiation and Ixabepilone For High Risk Prostate Cancer Post-Prostatectomy|
|Actual Study Start Date :||May 26, 2010|
|Actual Primary Completion Date :||October 17, 2011|
|Actual Study Completion Date :||October 17, 2011|
Procedure: adjuvant therapy
Radiation: intensity-modulated radiation therapy
- Dose-limiting toxicity (phase I) [ Time Frame: 3 years ]Dose-limiting toxicity (phase I)
- Maximum-tolerated dose (phase I) [ Time Frame: 3 years ]Maximum-tolerated dose (phase I)
- Freedom from progression for 3 years (phase II) [ Time Frame: 3 years ]Freedom from progression for 3 years (phase II)
- Time to biochemical, local and distant failure (phase II) [ Time Frame: 3 years ]Time to biochemical, local and distant failure (phase II)
- Disease-specific survival (phase II) [ Time Frame: 3 years ]Disease-specific survival (phase II)
- Overall survival rate (phase II) [ Time Frame: 3 years ]Overall survival rate (phase II)
- Adverse events as assessed by NCI CTCAE v. 4.0 [ Time Frame: 3 years ]Adverse events as assessed by NCI CTCAE v. 4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||David A. Pistenmaa, MD||Simmons Cancer Center|