A Phase 2 interventional study of Docetaxel, Carboplatin in Hormone-Refractory Prostate Cancer, sponsored by National University Hospital, Singapore. Completed at 1 site in Singapore. Open to male participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2012-04-02.
Sponsored by National University Hospital, Singapore · Phase 2, Interventional, and Treatment
The primary objective is to determine the efficacy of docetaxel plus carboplatin as first line treatment in patients with hormone refractory prostate cancer.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 2 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.
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Laboratory criteria for entry:
Exclusion Criteria:
Patients in study will receive both chemotherapeutic agents on day 1 and day 8 of every 21-day cycle as described below: * Docetaxel 30 mg/m2 over 1 hour IV infusion, followed by * Carboplatin (AUC 2) over 1 hour IV infusion * Additonal medication required: IV Dexamethasone 10 mg followed by PO dexamethasone 4 mg 8 hourly x 4 doses, starting 12 hours after starting iv docetaxel.
Drug: Docetaxel, Carboplatin
Docetaxel Form: A white, lyophilized powder in vials of 50, 150, and 450 mg each, which should be stored at room temperature in a light-protected area. Carboplatin Form: Taxotere is supplied as a sterile, non-aqueous, viscous solution with an accompanying sterile diluent (13% ethanol in water for injection). 20 and 80 mg strengths are available.
Also known as: Carboplatin (Paraplatin), Docetaxel (Taxotere®)
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.
Time frame: evaluated every 3 cycles (9 weeks)
duration of response and toxicity profile of docetaxel and carboplatin.
Time frame: during patient's treatment
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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National University Hospital, Singapore