Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	Other, Pharmaceutical / Industry	CRUK-TRAPEZE-2100 PR2100, EUDRACT-2004-002295-41, EU-20782, ISRCTN12808747, SANOFI-AVENTIS-CRUK-TRAPEZE-2100, NOVARTIS-CRUK-TRAPEZE-2100, NCT00554918

Objectives

Primary

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

Secondary

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

Tertiary

1. Compare median time to disease progression between the treatment groups.
2. Compare pain progression-free survival (PFS) between the treatment groups.
3. Compare PSA PFS between the treatment groups.
4. Compare pain response between the treatment groups.
5. Compare overall survival between the treatment groups.
6. Compare quality of life between the treatment groups.

Entry Criteria

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

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

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

Expected Enrollment

Outcomes

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

Health Care economic analysis
Changes in bone mineral density
Median time to disease progression
Pain progression-free survival (PFS)
PSA PFS
Pain response
Overall survival
Quality of life

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

Trial Contact Information

Trial Lead Organizations

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Nicholas James, MD, Protocol chair		Ph: 44-121-697-8314 Email: n.d.james@bham.ac.uk

United Kingdom
England
	Birmingham
	Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
		Nicholas James, MD	Ph:  44-121-697-8314
			Email: n.d.james@bham.ac.uk
	Cheltenham
	Gloucestershire Oncology Centre at Cheltenham General Hospital
		Contact Person	Ph:  44-8454-222-222
	Gloucester
	Gloucestershire Royal Hospital
		Contact Person	Ph:  44-1452-528-555
	Ipswich
	Ipswich Hospital
		Contact Person	Ph:  44-1473-712-233
	Maidstone
	Mid Kent Oncology Centre at Maidstone Hospital
		Contact Person	Ph:  44-1622-729-000
	Manchester
	Christie Hospital
		Contact Person	Ph:  44-845-226-3000
	Sutton
	Royal Marsden - Surrey
		Contact Person	Ph:  44-20-8642-6011
	Walsall
	Walsall Manor Hospital
		Contact Person	Ph:  44-1922-721-172
Scotland
	Aberdeen
	Aberdeen Royal Infirmary
		Contact Person	Ph:  44-84-5456-6000
	Ayr
	Ayr Hospital
		Contact Person	Ph:  44-1292-610-555
	Edinburgh
	Edinburgh Cancer Centre at Western General Hospital
		Contact Person	Ph:  44-131-537-1000
	Glasgow
	Beatson West of Scotland Cancer Centre
		Contact Person	Ph:  44-141-211-2123
	Kilmarnock
	Crosshouse Hospital
		Contact Person	Ph:  44-1563-521-133
	Wishaw
	Wishaw General Hospital
		Contact Person	Ph:  44-169-836-1100
Wales
	Cardiff
	Velindre Cancer Center at Velindre Hospital
		Contact Person	Ph:  44-29-2031-6292
	Rhyl, Denbighshire
	Glan Clwyd Hospital
		Contact Person	Ph:  44-1745-583-910

Registry Information
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.
Trial Start Date		2005-02-04
Trial Completion Date		2008-12-01 (estimated)
Registered in ClinicalTrials.gov		NCT00554918
Date Submitted to PDQ		2007-10-26
Information Last Verified		2008-04-06

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