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

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ClinicalTrials.gov Identifier: NCT00675545
Recruitment Status : Completed
First Posted : May 9, 2008
Last Update Posted : April 2, 2012
Sponsor:
Information provided by (Responsible Party):
Haematology-Oncology, National University Hospital, Singapore

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.

Condition or disease Intervention/treatment Phase
Hormone-Refractory Prostate Cancer Drug: Docetaxel, Carboplatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients
Study Start Date : May 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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®)




Primary Outcome Measures :
  1. efficacy of docetaxel plus carboplatin [ Time Frame: evaluated every 3 cycles (9 weeks) ]
    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.


Secondary Outcome Measures :
  1. duration of response and toxicity profile of docetaxel and carboplatin. [ Time Frame: during patient's treatment ]


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675545


Locations
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Singapore
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
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Principal Investigator: Alvin Wong, MD National University Hospital, Singapore

Publications:
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Responsible Party: Haematology-Oncology, Dr. Alvin Wong, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00675545     History of Changes
Other Study ID Numbers: PR01/30/06
First Posted: May 9, 2008    Key Record Dates
Last Update Posted: April 2, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carboplatin
Docetaxel
Hormones
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs