NCT00675545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

April 2, 2012

Status Verified

March 1, 2012

Enrollment Period

3 years

First QC Date

May 7, 2008

Last Update Submit

March 30, 2012

Conditions

Hormone-Refractory Prostate Cancer

Outcome Measures

Primary Outcomes (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.

    evaluated every 3 cycles (9 weeks)

Secondary Outcomes (1)

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

    during patient's treatment

Study Arms (1)

docetaxel and prednisolone

EXPERIMENTAL

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

Interventions

Docetaxel, CarboplatinDRUG

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.

Also known as: Carboplatin (Paraplatin), Docetaxel (Taxotere®)
docetaxel and prednisolone

Eligibility Criteria

Age30 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

Related Publications (2)

  • 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.

    PMID: 15470213BACKGROUND

  • 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.

    PMID: 14669278BACKGROUND

MeSH Terms

Interventions

DocetaxelCarboplatin

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Officials

  • Alvin Wong, MD

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Alvin Wong

Study Record Dates

First Submitted

May 7, 2008

First Posted

May 9, 2008

Study Start

May 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

April 2, 2012

Record last verified: 2012-03

Locations

SG(1)