A Phase II Study of Ara-C (Cytarabine) in Men With Androgen Independent Prostate Cancer
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
This is a single-arm, open label phase II trial of the investigational agent, Ara-C
(cytarabine), in patients diagnosed with hormone refractory prostate cancer whose disease has
progressed on or deemed not suitable for standard chemotherapy with docetaxel. Ara-C appears
to inhibit DNA synthesis and is cytotoxic to a wide variety of mammalian cells. Recent
discoveries have suggested the role of gene fusions in the ETS family of transcription
factors as important for the development of prostate cancer. Ara-C appears to block ETS
genes, suggesting that it is worthwhile to explore Ara-C as a potential new treatment for
patients with hormone refractory prostate cancer given that there is no standard of care for
the proposed patient population. In this study, Ara-C will be administered intravenously for
2 days every 3 weeks (1 cycle). Treatment will be for 6 cycles if tolerated and may be
continued in patients who are responding and do not have severe toxicity.