Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT00554918
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2007-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
University Hospital Birmingham
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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.
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: