NCT00811031撤回2 期
A Phase II Study of Pre-operative Docetaxel for Progressive Localized Castration Resistant Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Pre-to-post chemotherapy increase phosphorylation of platelet-derived growth factor receptor (PDGFR)
研究概览
简要总结
Objectives:
Primary:
- To evaluate the association of the probability of increase in phosphorylation of platelet-derived growth factor receptor (PDGFR) of > 0.5 in peripheral blood leucocytes following pre-operative docetaxel chemotherapy, with progression-free survival in localized castration-resistant prostate cancer (CRPC)
Secondary:
- To evaluate the association of the probability of increase in phosphorylated platelet-derived growth factor receptor (PDGFR) expression in peripheral blood leucocytes > 0.5 with indices of tumor regression including PSA-decline by 50% and measures of objective regression of tumor by transrectal MRI following pre-operative docetaxel therapy.
- Explore associations of probability of increase in phosphorylated PDGFR in peripheral blood leucocytes following pre-operative docetaxel therapy with plasma PDGF kinetics and spatial and quantitative PDGF and phosphorylated PDGFR expression in tumor and stromal compartments in resected specimens.
- Evaluate the association of probability of increase in phosphorylated PDGFR expression in peripheral blood leucocytes following pre-operative docetaxel chemotherapy with overall survival outcomes.
- Assess global quality of life measures at baseline and 6 and 12 months post-operatively.
- Create a tissue archive comprising tumor and peripheral blood specimens as a suitable resource for future genomic and proteomic studies.
详细描述
The Study Drugs:
Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die. It is believed to be weakly effective at killing blood vessels in cancer cells as well.
Prednisone and docetaxel are commonly used to treat prostate cancer.
Study Drug Administration:
If you are found to be eligible to take part in this study, on Day 1 of every 21-day study "cycle", you will receive docetaxel through a needle in your vein over 1 hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with adenocarcinoma of the prostate (ductal or acinar).
- •Symptomatic or evidence of progressive disease in the primary tumor by digital rectal examination, cystoscopy and/or radiological imaging without symptomatic or objective evidence of systemic disease progression.
- •Patients must have a castrate serum testosterone level (</= 50ng/ml) documented in the last six weeks. For patients who are medically castrated, luteinizing hormone releasing hormone analog must continue to maintain testicular suppression.
- •Patients on antiandrogens should be discontinued from flutamide, nilutamide or cyproterone acetate for at least 4 weeks and bicalutamide for 6 weeks. If localized progression is documented during or after this time interval, patients are eligible. Patients who have not had response to deferred (secondary) therapy with antiandrogens do not have to satisfy this waiting period prior to enrollment.
- •Surgically resectable disease as assessed by the collaborating urological oncologist.
- •Patients must be >/= 18 years of age.
- •Patients must have a performance status of </= 2 (ECOG).
- •Patients must have an expected survival from cancer or co-morbidity of six months.
- •Patients will not receive any concurrent biological, immunological, second-line hormonal therapy or chemotherapy. Patients receiving replacement or therapeutic doses of corticosteroid for non-malignant disease while disease progression was established may continue on such therapy.
- •Patients may not have received docetaxel or other chemotherapeutic agents in the last 6 months or have been defined as docetaxel-resistant or intolerant previously.
- •Patients must have adequate bone marrow function defined as an Hgb >/= 8.0 g/dl, absolute peripheral granulocyte count of >/= 1,500/mm^3 and platelet count of >/= 100,000/mm^
- •Patients must have adequate hepatic function defined with a bilirubin of </= upper limits of normal. AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used (see chart below in Study Plan).
- •Patients must have adequate renal function defined as creatinine clearance >/= 30 cc/min (measured or calculated by Cockcroft and Gault formula).
- •Must be fully recovered from any previous surgery, in terms of wound healing.
- •Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution.
- •Men with the ability to father a child must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
排除标准
- •Patients with severe or uncontrolled infection defined as symptomatic and/or requiring intravenous antibiotics.
- •Patients with small cell or sarcomatoid variant of prostate cancer.
- •Patients with symptomatic congestive heart failure (CHF), pulmonary embolus, vascular thrombosis, transient ischemic attack, cerebrovascular accident, unstable angina or MI in the last 6 months or evidence of active myocardial ischemia by symptoms or ECG.
- •Oxygen-dependent lung disease, > grade 2 peripheral neuropathy, uncontrolled hypertension or uncontrolled diabetes mellitus.
- •Active second malignancies. Non-threatening second malignancies such as superficial low-grade transitional cell carcinoma of the bladder, Rai Stage 0 chronic lymphocytic leukemia or stable small renal cell carcinomas may be exempt from such stipulation at the discretion of the Principal Investigator.
- •Patients who are unwilling to provide blood or tissue specimens required for the primary objectives of the study.
- •Overt psychosis or mental disability or otherwise incompetent to give informed consent. Patients with a history of non-compliance with medical regimens or who are considered potentially unreliable.
- •Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.
研究组 & 干预措施
Taxotere + Prednisone
Experimental
干预措施: Taxotere (Drug)
Taxotere + Prednisone
Experimental
干预措施: Prednisone (Drug)
结局指标
主要结局
Pre-to-post chemotherapy increase phosphorylation of platelet-derived growth factor receptor (PDGFR)
时间窗: PDGFR will be estimated for each patient based on blood samples taken at day 0 and at day 42 using the Bayesian survival time regression model.
次要结局
未报告次要终点
研究者
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