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Hormone-Refractory Prostate CancerPhase 2NCT00675545

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

A Phase 2 study testing Docetaxel, Carboplatin in people with Hormone-Refractory Prostate Cancer, run by National University Hospital, Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 30 years and older, men only
Conditions the study is for
Hormone-Refractory Prostate Cancer
What is being tested?
Docetaxel, Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteSingapore
Study dates
May 2007to May 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National University Hospital

    Singapore

Other trials in Singapore

About this study

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

Read the 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.

Being tested
Docetaxel, Carboplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docetaxel, CarboplatinDrug

    Also called Carboplatin (Paraplatin), Docetaxel (Taxotere®)

    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.

Study groups in NCT00675545
Study groupRoleWhat they receive
docetaxel and prednisoloneExperimentalPatients 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.
Receives: Drug: Docetaxel, Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. efficacy of docetaxel plus carboplatin

    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.

    Measured: evaluated every 3 cycles (9 weeks)

Secondary outcomes (1)

  1. duration of response and toxicity profile of docetaxel and carboplatin.

    Measured: during patient's treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2008 (estimated)
  2. Study startMay 2007
  3. Primary completionMay 2010
  4. Study completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00675545
Sponsor's protocol ID
PR01/30/06
Status last verified
Mar 2012
First submitted
7 May 2008
Last updated
2 Apr 2012
Results posted
No
Data monitoring committee
No

Publications

  • Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.

    PubMed 15470213

  • Oh WK, Halabi S, Kelly WK, Werner C, Godley PA, Vogelzang NJ, Small EJ; Cancer and Leukemia Group B 99813. A phase II study of estramustine, docetaxel, and carboplatin with granulocyte-colony-stimulating factor support in patients with hormone-refractory prostate carcinoma: Cancer and Leukemia Group B 99813. Cancer. 2003 Dec 15;98(12):2592-8. doi: 10.1002/cncr.11829.

    PubMed 14669278

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Carboplatin in people with Hormone-Refractory Prostate Cancer, run by National University Hospital, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

efficacy of docetaxel plus carboplatin (time frame: evaluated every 3 cycles (9 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00675545, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2012.

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