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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objective is to determine the efficacy of docetaxel plus carboplatin as first line treatment in patients with hormone refractory prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore
• Treatments: Carboplatin; Docetaxel; Hormones

Criteria

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.