AzTrials
AzTrials

Metastatic CancerPhase 2NCT00554918

Docetaxel and Prednisolone With or Without Zoledronic Acid and/or Strontium Chloride Sr 89 in Treating Patients With Prostate Cancer Metastatic to Bone That Has Not Responded to Hormone Therapy

A Phase 2 study testing docetaxel, prednisolone and zoledronic acid in people with Metastatic Cancer and Prostate Cancer, run by University Hospital Birmingham at 16 sites in United Kingdom.

Completed

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

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisolone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Zoledronic acid may help relieve some of the symptoms caused by bone metastases. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Cancer, Prostate Cancer
What is being tested?
docetaxel, prednisolone and zoledronic acid
Type of treatment
Surgery or procedure
How many people
300 participants
Where
16 sitesUnited Kingdom
Study dates
Feb 2005to Jun 2013
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:
  • Histologically or cytologically proven prostate adenocarcinoma
  • Multiple sclerotic bone metastases with PSA ≥ 100 ng/mL without histological confirmation
  • Radiological evidence of bone metastasis
  • Prior hormonal therapy for prostate cancer including ≥ 1 of the following:
  • Bilateral orchidectomy
  • Medical castration by luteinizing hormone-releasing hormone (LHRH) agonist therapy
  • If receiving LHRH agonist therapy alone, this therapy should be continued
  • Documented disease progression, defined by one of the following:
  • Progressive disease after discontinuing hormone therapy
  • Elevated and rising PSA, defined as 2 consecutive increases in PSA documented over a previous reference value
  • PSA > 5ng/mL
  • Progression of any unidimensionally or bidimensionally measurable malignant lesion
  • At least 1 new lesion identified on bone scan
  • No known brain or leptomeningeal metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Hemoglobin ≥ 10g/dL
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 1.5 times ULN (unless related to hepatic metastatic disease, where patients may be entered after discussion with one of the clinical advisors)
  • Serum bilirubin ≤ 1.5 times ULN
  • Physically fit enough to receive trial treatment
  • No malignant disease within the past 5 years, other than adequately treated basal cell carcinoma
  • No symptomatic peripheral neuropathy ≥ grade 2 (NCI CTC)
  • No known hypersensitivity to bisphosphonates
  • No condition, in the opinion of the investigator, that may interfere with the safety of the patient or evaluation of the study objectives

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior flutamide, nilutamide, or cyproterone acetate with evidence of disease progression since cessation
  • At least 6 weeks since prior bicalutamide with evidence of disease progression since cessation
  • At least 4 weeks since prior estramustine and any adverse events must have resolved
  • At least 2 months since prior treatment with a bisphosphonate for any reason
  • No treatment with any other investigational compound within the past 30 days
  • No prior cytotoxic chemotherapy for hormone refractory prostate cancer (HRPC), other than estramustine monotherapy
  • No prior radionuclide therapy for HRPC
  • No prior radiotherapy to more than 25% of the bone marrow or whole pelvic irradiation
  • No concurrent enrollment in any other investigational clinical trial

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United Kingdom16 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Ayr Hospital

    Ayr, Scotland, KA6 6DX

  • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

    Birmingham, England, B15 2TH

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales, CF14 2TL

  • Gloucestershire Oncology Centre at Cheltenham General Hospital

    Cheltenham, England, GL53 7AN

  • Edinburgh Cancer Centre at Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Beatson West of Scotland Cancer Centre

    Glasgow, Scotland, G12 0YN

  • Gloucestershire Royal Hospital

    Gloucester, England, GL1 3NN

  • Ipswich Hospital

    Ipswich, England, IP4 5PD

  • Crosshouse Hospital

    Kilmarnock, Scotland, KA2 OBE

  • Mid Kent Oncology Centre at Maidstone Hospital

    Maidstone, England, ME16 9QQ

  • Christie Hospital

    Manchester, England, M20 4BX

  • Glan Clwyd Hospital

    Rhyl, Denbighshire, Wales, LL 18 5UJ

  • Royal Marsden - Surrey

    Sutton, England, SM2 5PT

  • Walsall Manor Hospital

    Walsall, England, WS2 9PS

  • Wishaw General Hospital

    Wishaw, Scotland, ML2 0DP

Other trials in United Kingdom

About this study

Official title: A Randomised Phase II Feasibility Study of Docetaxel (Taxotere®) Plus Prednisolone vs. Docetaxel (Taxotere®) Plus Prednisolone Plus Zoledronic Acid (Zometa®) vs. Docetaxel (Taxotere®) Plus Prednisolone Plus Strontium-89 vs. Docetaxel (Taxotere®) Plus Prednisolone Plus Zoledronic Acid (Zometa®) Plus Strontium-89 in Hormone Refractory Prostate Cancer Metastatic to Bone.

RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisolone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Zoledronic acid may help relieve some of the symptoms caused by bone metastases. Radioactive substances, such as strontium chloride Sr 89, may help relieve bone pain caused by prostate cancer. Giving docetaxel together with prednisolone with or without zoledronic acid and/or strontium chloride Sr 89 may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying the side effects and how well giving docetaxel together with prednisolone works with or without zoledronic acid and/or strontium chloride Sr 89 in treating patients with prostate cancer metastatic to bone that has not responded to hormone therapy.

Read the detailed description

OBJECTIVES:

Primary

  • To assess the toxicity and tolerability of docetaxel with zoledronic acid.
  • To assess the toxicity and tolerability of docetaxel with strontium chloride Sr 89.
  • To assess the toxicity and tolerability of docetaxel with zoledronic acid and strontium chloride Sr 89.

Secondary

  • Compare health economic endpoints between the treatment groups.
  • Compare changes in bone mineral density between the treatment groups.
  • Compare the biological profiling for prognostic and predictive indicators between the treatment groups.

Tertiary

  • Compare median time to disease progression between the treatment groups.
  • Compare pain progression-free survival (PFS) between the treatment groups.
  • Compare PSA PFS between the treatment groups.
  • Compare pain response between the treatment groups.
  • Compare overall survival between the treatment groups.
  • Compare quality of life between the treatment groups.

OUTLINE: This is a multicenter study. Patients are stratified according to treatment center and ECOG performance status (0 vs 1 vs 2). Patients are randomized to 1 of 4 treatment arms.

  • Arm I: Patients receive docetaxel IV on day 1 and oral prednisolone once daily.
  • Arm II: Patients receive docetaxel and prednisolone as in arm I and zoledronic acid IV over 15 minutes on day 1.
  • Arm III: Patients receive docetaxel and prednisolone as in arm I and a single dose of strontium chloride Sr 89 IV on day 7 of course 2.
  • Arm IV: Patients receive docetaxel and prednisolone as in arm I, zoledronic acid as in arm II, and strontium chloride Sr 89 as in arm III.

Treatment with docetaxel, prednisolone, and zoledronic acid repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Strontium chloride Sr 89 is given as a one time single dose.

Quality of life is assessed using the Euroqual (EQ-5D) and FACT-P at baseline and every 3 months during follow up.

After completion of study, patients are followed every 3 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

Being tested
docetaxel, prednisolone, zoledronic acid, quality-of-life assessment, strontium chloride Sr 89
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer, bone metastases
Medical subject headings
Neoplasm Metastasis, Prostatic Neoplasms

What participants receive

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

What is being measured

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

  1. Safety

  2. Toxicity and tolerability of docetaxel and zoledronic acid

  3. Toxicity and tolerability of docetaxel and strontium chloride Sr 89

  4. Toxicity and tolerability of docetaxel, zoledronic acid, and strontium chloride Sr 89

Secondary outcomes (8)

  1. Health Care economic analysis

  2. Changes in bone mineral density

  3. Median time to disease progression

  4. Pain progression-free survival (PFS)

  5. PSA PFS

  6. Pain response

  7. Overall survival

  8. Quality of life

Timeline

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

  1. First posted7 Nov 2007 (estimated)
  2. Study startFeb 2005
  3. Primary completionDec 2008
  4. Study completionJun 2013

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
Randomised
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00554918
Sponsor's protocol ID
CRUK-TRAPEZE-2100
Other IDs
CDR0000574585, EUDRACT-2004-002295-41, EU-20782, ISRCTN12808747, SANOFI-AVENTIS-CRUK-TRAPEZE-21, NOVARTIS-CRUK-TRAPEZE-2100
Status last verified
Apr 2008
First submitted
6 Nov 2007
Last updated
7 Aug 2013
Results posted
No

Publications

  • Jakob T, Tesfamariam YM, Macherey S, Kuhr K, Adams A, Monsef I, Heidenreich A, Skoetz N. Bisphosphonates or RANK-ligand-inhibitors for men with prostate cancer and bone metastases: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 3;12(12):CD013020. doi: 10.1002/14651858.CD013020.pub2.

    PubMed 33270906

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel, prednisolone and zoledronic acid in people with Metastatic Cancer and Prostate Cancer, run by University Hospital Birmingham at 16 sites in United Kingdom.

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

Who may be eligible to take part?

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 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United Kingdom. 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?

Safety. The study lists 4 primary outcomes in all. 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 NCT00554918, which also lists 1 linked publication.

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 7 Aug 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in