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.
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
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Safety
Yes
Nicholas D. James, MD
Study Chair
University Hospital Birmingham
Unspecified
CDR0000574585
NCT00554918
February 2005
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