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Sponsored by: |
National University Hospital, Singapore |
Information provided by: | National University Hospital, Singapore |
ClinicalTrials.gov Identifier: | NCT00675545 |
The primary objective is to determine the efficacy of docetaxel plus carboplatin as first line treatment in patients with hormone refractory prostate cancer.
Condition | Intervention | Phase |
Hormone-Refractory Prostate Cancer |
Drug: Docetaxel, Carboplatin |
Phase II |
MedlinePlus related topics: | Cancer Prostate Cancer |
Drug Information available for: | Carboplatin Docetaxel |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Efficacy Study |
Official Title: | A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients |
Estimated Enrollment: | 29 |
Study Start Date: | May 2007 |
Docetaxel-prednisolone is the current standard in HRPC, based on 2 large randomized trials showing improved survival compared to mitoxantrone-prednisolone. Carboplatin has activity in prostate cancer and the combination of Docetaxel-carboplatin is known to be synergistic and is used with good effect in many cancers. The advantage of using this combination in prostate cancer is suported by clinical data: high response rates of docetaxel-carboplatin-estramustine (with G-CSF support) in a phase II trial (Oh, Halabi, Kelly et al. Cancer. 2003 Dec 15;98(12):2592-8), and additional effect of this combination in prior taxane failures (Oh, George, Tay. Clin Prostate Cancer. 2005 Jun;4(1):61-4). Carboplatin itself has activity and theoretically could target the more hormone resistant clones or neuroendocrine components of the tumor.(Di Sant' Agnese. J Urol. 1994 Nov;152(5 Pt 2):1927-31.) We are studying the combination of docetaxel-carboplatin both given in a weekly, low-dose fashion, without estramustine and without G-CSF. This is expected to be an effective and tolerable treatment for HRPC patients. We will be documenting (to our knowledge) for the first time in this trial the efficacy of the combination given in this particular dose and schedule.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory criteria for entry:
Exclusion Criteria:
Contact: Alvin Wong, MD | 65-6772-2527 | Alvin_SC_Wong@nuh.com.sg |
Singapore | |||||
National University Hospital | Recruiting | ||||
Singapore, Singapore | |||||
Contact: Alvin Wong, MD 65-6772-2527 Alvin_SC_Wong@nuh.com.sg | |||||
Principal Investigator: Alvin Wong, MD |
National University Hospital, Singapore |
Principal Investigator: | Alvin Wong, MD | National University Hospital, Singapore |
Responsible Party: | National University of Singapore ( Dr Alvin Wong ) |
Study ID Numbers: | PR01/30/06 |
First Received: | May 7, 2008 |
Last Updated: | May 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00675545 |
Health Authority: | Singapore: Domain Specific Review Boards |
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