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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Haematology-Oncology, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00675545
First received: May 7, 2008
Last updated: March 30, 2012
Last verified: March 2012
History of Changes

May 7, 2008
March 30, 2012
May 2007
May 2010   (final data collection date for primary outcome measure)
efficacy of docetaxel plus carboplatin [ Time Frame: evaluated every 3 cycles (9 weeks) ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00675545 on ClinicalTrials.gov Archive Site
duration of response and toxicity profile of docetaxel and carboplatin. [ Time Frame: during patient's treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients
A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients

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.
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hormone-Refractory Prostate Cancer
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.

Other Names:
  • Carboplatin (Paraplatin)
  • Docetaxel (Taxotere®)
Experimental: docetaxel and prednisolone

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.
Intervention: Drug: Docetaxel, Carboplatin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
May 2010
May 2010   (final data collection date for primary outcome measure)

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.
Male
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00675545
PR01/30/06
No
Haematology-Oncology, National University Hospital, Singapore
National University Hospital, Singapore
Not Provided
Principal Investigator: Alvin Wong, MD National University Hospital, Singapore
National University Hospital, Singapore
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP