Hormone-Refractory Prostate Cancer
Conditions
Brief summary
The primary objective is to determine the efficacy of docetaxel plus carboplatin as first line treatment in patients with hormone refractory prostate cancer.
Detailed description
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.
Interventions
DRUGDocetaxel, 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.
Sponsors
National University Hospital, Singapore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed adenocarcinoma of the prostate. 2. At the time of enrollment, patients must have evidence of metastatic disease, with either measurable disease per RECIST criteria or non- measurable disease (i.e. positive bones scan) and PSA \> 5 ng/mm3. 3. Disease progression following androgen deprivation therapy. 4. Progression is defined according to the PSA Working Group criteria (see 6.1.3 and 6.3). 5. Serum testosterone levels \< 50 ng/mm3 (unless surgically castrate). Patients must continue androgen deprivation with an LHRH analogue if they have not undergone orchiectomy. 6. No use of an antiandrogen for at least 4 weeks. 7. Have not been treated with chemotherapy before. 8. ECOG performance status of \<= 2. 9. Laboratory criteria for entry: * White blood cell (WBC) =\> 3000/mm3 * Platelets =\> 100,000/mm3 * AST \< 2.5 x upper limit of normal * Calculated CCT of =\> 40 ml/min 10. Signed informed consent form. 11. Age: 30 years old and above
Exclusion criteria
1. Significant peripheral neuropathy defined as grade 2 or higher. 2. Within 4 weeks since completing external beam radiotherapy or 8 weeks since completing radiopharmaceutical therapy (strontium, samarium). 3. Concomitant chemotherapy or investigational agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of docetaxel plus carboplatin | evaluated every 3 cycles (9 weeks) | 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. |
Secondary
| Measure | Time frame |
|---|---|
| duration of response and toxicity profile of docetaxel and carboplatin. | during patient's treatment |
Countries
Singapore
Outcome results
None listed