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Sponsored by: |
University Health Network, Toronto |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00480090 |
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 mamalian 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.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Ara-C (Cytarabine) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Ara-C (Cytarabine) in Men With Androgen Independent Prostate Cancer |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anthony Joshua, MD | 416-946-4501 | anthony.joshua@utoronto.ca |
Canada, Ontario | |
University Health Network | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Principal Investigator: Anthony Joshua, MD |
Principal Investigator: | Ian Tannock, MD | University Health Network, Toronto |
Study ID Numbers: | SLAP41206 |
Study First Received: | May 28, 2007 |
Last Updated: | June 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00480090 |
Health Authority: | Canada: Health Canada |
Prostate Androgen independent Phase II Second line Androgen-independent prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Prostatic Neoplasms Cytarabine |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses |