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A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients

Phase 2
30 Years
Not Enrolling
Hormone-Refractory Prostate Cancer

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Trial Information

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.

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

5. Serum testosterone levels < 50 ng/mm3 (unless surgically castrate). Patients must
continue androgen deprivation with an LHRH analogue if they have not undergone

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

efficacy of docetaxel plus carboplatin

Outcome Description:

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.

Outcome Time Frame:

evaluated every 3 cycles (9 weeks)

Safety Issue:


Principal Investigator

Alvin Wong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

May 2007

Completion Date:

May 2010

Related Keywords:

  • Hormone-Refractory Prostate Cancer
  • Prostatic Neoplasms