drugset / Trial / NCT00331344
Treating Patients With Metastatic Prostate Cancer Not Responding to Hormone and Chemotherapy
SequentialOpen-labelTreatment
Summary
This phase I/II trial is studying the side effects and best dose of ixabepilone and mitoxantrone hydrochloride when given together with prednisone and to see how well they work in treating patients with metastatic prostate cancer that did not respond to hormone therapy and chemotherapy. Drugs used in chemotherapy, such as ixabepilone, mitoxantrone hydrochloride, and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells
Timeline
- Start
- 2006-04
- Primary completion
- 2010-11
- Completion
- 2010-11
Publications
- Results Rosenberg JE, Ryan CJ, Weinberg VK, Smith DC, Hussain M, Beer TM, Ryan CW, Mathew P, Pagliaro LC, Harzstark AL, Sharib J, Small EJ. Phase I study of ixabepilone, mitoxantrone, and prednisone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based therapy: a study of the department of defense prostate cancer clinical trials consortium. J Clin Oncol. 2009 Jun 10;27(17):2772-8. doi: 10.1200/JCO.2008.19.8002. Epub 2009 Apr 6.
- Results Harzstark AL, Rosenberg JE, Weinberg VK, Sharib J, Ryan CJ, Smith DC, Pagliaro LC, Beer TM, Liu G, Small EJ. Ixabepilone, mitoxantrone, and prednisone for metastatic castration-resistant prostate cancer after docetaxel-based therapy: a phase 2 study of the Department Of Defense Prostate Cancer Clinical Trials Consortium. Cancer. 2011 Jun 1;117(11):2419-25. doi: 10.1002/cncr.25810. Epub 2010 Dec 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ixabepilone | Small molecule | 35 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 12 mg/m2 | Intravenous |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |