Pemetrexed as Second-Line Therapy in Treating Patients With Hormone Refractory Prostate Cancer

Summary

Docetaxel-based therapy has been shown to prolong survival as first-line therapy for patients with hormone refractory prostate cancer (HRPC), and has become the standard of care. The beneficial effects of any therapy in HRPC may be diverse and include reduction in tumor bulk (when measurable), reduction in prostate-specific antigen PSA, reduction in symptoms (particularly pain), or stabilization of disease. Clear reductions in tumor bulk or PSA may provide objective evidence of a treatment effect, and stabilization of disease may be just as clinically meaningful in patients who are actively progressing prior to starting therapy. Pemetrexed has shown a broad array of activity in many diseases that until now were thought to be non-responsive to chemotherapy in the second-line setting. This trial is designed to further assess the efficacy, safety, tolerability, and pharmacogenetics of pemetrexed as a single agent in subjects with HRPC whose disease has progressed following one prior taxane-based chemotherapy regimen for HRPC.

Timeline

Start

2005-02

Primary completion

2009-03

Completion

2009-03

Publications

• Results Hahn NM, Zon RT, Yu M, Ademuyiwa FO, Jones T, Dugan W, Whalen C, Shanmugam R, Skaar T, Sweeney CJ. A phase II study of pemetrexed as second-line chemotherapy for the treatment of metastatic castrate-resistant prostate cancer (CRPC); Hoosier Oncology Group GU03-67. Ann Oncol. 2009 Dec;20(12):1971-6. doi: 10.1093/annonc/mdp244. Epub 2009 Jul 15.

Drugs

Indications