S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan 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. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective than docetaxel and prednisone in treating prostate cancer. PURPOSE: This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy.

Timeline

Start

2006-08

Primary completion

2016-02

Completion

2016-02

Publications

• Results Goldkorn A, Ely B, Quinn DI, et al.: Results of telomerase activity measurements from live circulating tumor cells captured on a slot microfilter in a phase III SWOG-coordinated prostate cancer trial (S0421). [Abstract] J Clin Oncol 30 (Suppl 15): A-4663, 2012.
• Results Lara P, Ely B, Quinn DI, et al.: SWOG 0421: prognostic and predictive value of bone metabolism biomarkers (BMB) in castration resistant prostate cancer (CRPC) patients (pts) with skeletal metastases treated with docetaxel (DOC) with or without atrasentan (ATR). [Abstract] J Clin Oncol 30 (Suppl 15): A-4547, 2012.
• Results Quinn DI, Tangen CM, Hussain M, et al.: SWOG S0421: phase III study of docetaxel (D) and atrasentan (A) versus docetaxel and placebo (P) for men with advanced castrate resistant prostate cancer (CRPC). [Abstract] J Clin Oncol 30 (Suppl 15): A-4511, 2012.
• Results Goldkorn A, Ely B, Quinn DI, Tangen CM, Fink LM, Xu T, Twardowski P, Van Veldhuizen PJ, Agarwal N, Carducci MA, Monk JP 3rd, Datar RH, Garzotto M, Mack PC, Lara P Jr, Higano CS, Hussain M, Thompson IM Jr, Cote RJ, Vogelzang NJ. Circulating tumor cell counts are prognostic of overall survival in SWOG S0421: a phase III trial of docetaxel with or without atrasentan for metastatic castration-resistant prostate cancer. J Clin Oncol. 2014 Apr 10;32(11):1136-42. doi: 10.1200/JCO.2013.51.7417. Epub 2014 Mar 10.
• Results Goldkorn A, Xu T, Lu B, et al.: Circulating tumor cell capture and analysis in a multicenter SWOG-coordinated prostate cancer trial. [Abstract] J Clin Oncol 28 (Suppl 15): A-TPS342, 2010.
• Lara PN Jr, Ely B, Quinn DI, Mack PC, Tangen C, Gertz E, Twardowski PW, Goldkorn A, Hussain M, Vogelzang NJ, Thompson IM, Van Loan MD. Serum biomarkers of bone metabolism in castration-resistant prostate cancer patients with skeletal metastases: results from SWOG 0421. J Natl Cancer Inst. 2014 Apr;106(4):dju013. doi: 10.1093/jnci/dju013. Epub 2014 Feb 24.
• Quinn DI, Tangen CM, Hussain M, Lara PN Jr, Goldkorn A, Moinpour CM, Garzotto MG, Mack PC, Carducci MA, Monk JP, Twardowski PW, Van Veldhuizen PJ, Agarwal N, Higano CS, Vogelzang NJ, Thompson IM Jr. Docetaxel and atrasentan versus docetaxel and placebo for men with advanced castration-resistant prostate cancer (SWOG S0421): a randomised phase 3 trial. Lancet Oncol. 2013 Aug;14(9):893-900. doi: 10.1016/S1470-2045(13)70294-8. Epub 2013 Jul 17.

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Indications