NCT00554918已完成2 期
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.
University Hospital Birmingham32 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2005年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 32
- 主要终点
- Toxicity and tolerability of docetaxel, zoledronic acid, and strontium chloride Sr 89
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Toxicity and tolerability of docetaxel, zoledronic acid, and strontium chloride Sr 89
Safety
Toxicity and tolerability of docetaxel and zoledronic acid
Toxicity and tolerability of docetaxel and strontium chloride Sr 89
次要结局
- Quality of life
- Changes in bone mineral density
- Median time to disease progression
- Pain response
- Health Care economic analysis
- Pain progression-free survival (PFS)
- PSA PFS
- Overall survival
研究者
研究点 (32)
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