Know Cancer

or
forgot password

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.


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Metastatic Cancer, Prostate Cancer

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Safety

Safety Issue:

Yes

Principal Investigator

Nicholas D. James, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Birmingham

Authority:

Unspecified

Study ID:

CDR0000574585

NCT ID:

NCT00554918

Start Date:

February 2005

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage IV prostate cancer
  • bone metastases
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location