Status:
COMPLETED
A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Hormone-Refractory Prostate Cancer
Eligibility:
MALE
30+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the prostate.
- 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.
- Disease progression following androgen deprivation therapy.
- Progression is defined according to the PSA Working Group criteria (see 6.1.3 and 6.3).
- Serum testosterone levels \< 50 ng/mm3 (unless surgically castrate). Patients must continue androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.
- No use of an antiandrogen for at least 4 weeks.
- Have not been treated with chemotherapy before.
- ECOG performance status of \<= 2.
- 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
- Signed informed consent form.
- Age: 30 years old and above
Exclusion
- Significant peripheral neuropathy defined as grade 2 or higher.
- Within 4 weeks since completing external beam radiotherapy or 8 weeks since completing radiopharmaceutical therapy (strontium, samarium).
- Concomitant chemotherapy or investigational agents.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00675545
Start Date
May 1 2007
End Date
May 1 2010
Last Update
April 2 2012
Active Locations (1)
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1
National University Hospital
Singapore, Singapore