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

Sponsor
National University Hospital, Singapore (Other)
Overall Status
Completed
CT.gov ID
NCT00675545
Collaborator
(none)
2
Enrollment
1
Location
1
Arm
36
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
N/A
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 1, 2007
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

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®)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. efficacy of docetaxel plus carboplatin [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. [during patient's treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    1. Signed informed consent form.

    2. 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

    Locations

    Site City State Country Postal Code
    1 National University Hospital Singapore Singapore

    Sponsors and Collaborators

    • National University Hospital, Singapore

    Investigators

    • Principal Investigator: Alvin Wong, MD, National University Hospital, Singapore

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Haematology-Oncology, Dr. Alvin Wong, National University Hospital, Singapore
    ClinicalTrials.gov Identifier:
    NCT00675545
    Other Study ID Numbers:
    • PR01/30/06
    First Posted:
    May 9, 2008
    Last Update Posted:
    Apr 2, 2012
    Last Verified:
    Mar 1, 2012
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Carboplatin
    Docetaxel

    Study Results

    No Results Posted as of Apr 2, 2012