A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
efficacy of docetaxel plus carboplatin
The primary endpoint of the study is best overall response (complete or partial response) obtained from measurable target lesion or PSA, as defined using the modified RECIST criteria.
evaluated every 3 cycles (9 weeks)
Alvin Wong, MD
National University Hospital, Singapore
Singapore: Domain Specific Review Boards