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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00554918
First received: November 6, 2007
Last updated: August 6, 2013
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Metastatic Cancer
Prostate Cancer
Drug: docetaxel
Drug: prednisolone
Drug: zoledronic acid
Procedure: quality-of-life assessment
Radiation: strontium chloride Sr 89
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Toxicity and tolerability of docetaxel and zoledronic acid [ Designated as safety issue: Yes ]
  • Toxicity and tolerability of docetaxel and strontium chloride Sr 89 [ Designated as safety issue: Yes ]
  • Toxicity and tolerability of docetaxel, zoledronic acid, and strontium chloride Sr 89 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Health Care economic analysis [ Designated as safety issue: No ]
  • Changes in bone mineral density [ Designated as safety issue: No ]
  • Median time to disease progression [ Designated as safety issue: No ]
  • Pain progression-free survival (PFS) [ Designated as safety issue: No ]
  • PSA PFS [ Designated as safety issue: No ]
  • Pain response [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: February 2005
Study Completion Date: June 2013
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554918

Locations
United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN
Gloucestershire Royal Hospital
Gloucester, England, United Kingdom, GL1 3NN
Ipswich Hospital
Ipswich, England, United Kingdom, IP4 5PD
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, United Kingdom, ME16 9QQ
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Walsall Manor Hospital
Walsall, England, United Kingdom, WS2 9PS
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Ayr Hospital
Ayr, Scotland, United Kingdom, KA6 6DX
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G12 0YN
Crosshouse Hospital
Kilmarnock, Scotland, United Kingdom, KA2 OBE
Wishaw General Hospital
Wishaw, Scotland, United Kingdom, ML2 0DP
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom, CF14 2TL
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
Sponsors and Collaborators
University Hospital Birmingham
Investigators
Study Chair: Nicholas D. James, MD University Hospital Birmingham
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00554918     History of Changes
Other Study ID Numbers: CRUK-TRAPEZE-2100, CDR0000574585, EUDRACT-2004-002295-41, EU-20782, ISRCTN12808747, SANOFI-AVENTIS-CRUK-TRAPEZE-21, NOVARTIS-CRUK-TRAPEZE-2100
Study First Received: November 6, 2007
Last Updated: August 6, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer
bone metastases

Additional relevant MeSH terms:
Bone Marrow Diseases
Bone Neoplasms
Neoplasm Metastasis
Prostatic Neoplasms
Bone Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Hematologic Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Prostatic Diseases
Urogenital Neoplasms
Diphosphonates
Docetaxel
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Zoledronic acid
Anti-Inflammatory Agents
Antiemetics
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on October 23, 2014