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

This study is currently recruiting participants.
Verified by National University Hospital, Singapore, May 2008

Sponsored by: National University Hospital, Singapore
Information provided by: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00675545
  Purpose

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


Condition Intervention Phase
Hormone-Refractory Prostate Cancer
Drug: Docetaxel, Carboplatin
Phase II

MedlinePlus related topics:   Cancer    Prostate Cancer   

Drug Information available for:   Carboplatin    Docetaxel   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Efficacy Study
Official Title:   A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients

Further study details as provided by National University Hospital, Singapore:

Estimated Enrollment:   29
Study Start Date:   May 2007

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.

  Eligibility
Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675545

Contacts
Contact: Alvin Wong, MD     65-6772-2527     Alvin_SC_Wong@nuh.com.sg    

Locations
Singapore
National University Hospital     Recruiting
      Singapore, Singapore
      Contact: Alvin Wong, MD     65-6772-2527     Alvin_SC_Wong@nuh.com.sg    
      Principal Investigator: Alvin Wong, MD            

Sponsors and Collaborators
National University Hospital, Singapore

Investigators
Principal Investigator:     Alvin Wong, MD     National University Hospital, Singapore    
  More Information


Publications:

Responsible Party:   National University of Singapore ( Dr Alvin Wong )
Study ID Numbers:   PR01/30/06
First Received:   May 7, 2008
Last Updated:   May 8, 2008
ClinicalTrials.gov Identifier:   NCT00675545
Health Authority:   Singapore: Domain Specific Review Boards

Study placed in the following topic categories:
Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Carboplatin
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2008




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