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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Birmingham
• Treatments: Diphosphonates; Docetaxel; Hormones; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Zoledronic Acid

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