EUCTR2005-003275-20-SE进行中（未招募）不适用
A Phase 3 Randomized, Open-Label Study of Docetaxel in Combination with CG1940 and CG8711 versus Docetaxel and Prednisone in Taxane-Naïve Patients with Metastatic Hormone-Refractory Prostate Cancer With Pain - G-0034
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
- •2Males greater than 18 years of age
- •3Patients taking any Level 3 (Opioid)pain medication at any dose with any frequency. Patients taking Level 2 (Moderate) pain medication for cancer related pain, confirmed by investigator assessment. In order to assess the source of pain and the pain medication level, the investigator should review the patient’s completed assessment(s) of pain, perform a complete medical history, including current medications and physical examination, and review results from bone and CT scans.
- •4Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy (after discontinuation of anti-androgen therapy) as determined by one of the following:
- •Progressive measurable disease on CT scan or MRI as assessed using un-modified RECIST guidelines.
- •Progressive non-measurable disease as defined by the appearance of one or more new lesions on bone scan.
- •PSA progression, as defined by two consecutive rising PSA values obtained at least 2 weeks apart, and both obtained at least 4 weeks after discontinuation of any other anti-androgen therapy. The second PSA value must be = 5.0 ng/mL.
- •5Detectable metastases by bone scan, CT scan or MRI.
- •6Testosterone < 50 ng/dL (1.73 nmol/L). Must have had orchiectomy or is currently receiving an LHRH agonist/antagonist
- •7WBC = 3,000 cells/mm3, ANC > 1,500 cells/mm3, hemoglobin = 9 g/dL (5.6 mmol/L), and platelets = 100,000 cells/mm3
- •8Serum creatinine < 2.0 mg/dL (177 µmol/L)
- •9Total or direct bilirubin = the upper limit of normal
- •10AST or ALT = 1.5 times the upper limit of normal concomitant with alkaline phosphatase = 2.5 times the upper limit of normal.
- •11CD4+ lymphocytes > 200 cells/mm3
- •12ECOG performance status = 2 (performance status of 3 is allowed if due to bone pain)
- •13Life expectancy of at least 6 months
- •14If sexually active, willing to use barrier contraception during study drug treatment
- •15The ability to understand and the willingness to sign a written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
- •2Clinical evidence of brain metastases or history of brain metastases
- •3Third space fluid accumulation, such as ascites or symptomatic pleural effusion
- •4Clinically significant active infection or uncontrolled medical condition considered high-risk for docetaxel, corticosteroids or investigational new drug treatment
- •5Prior gene therapy or cancer vaccine for prostate cancer
- •6More than one prior systemic chemotherapy regimen, or any taxane chemotherapy. Patients must have completed chemotherapy at least 4 weeks prior to randomization and have recovered from all side effects.
- •7Radiation therapy within 4 weeks of randomization. Prior radiation must have been to less than 30% of the bone marrow and patient has recovered from all side effects. Prior use of samarium is acceptable; patients cannot have received strontium
- •8Surgery within 4 weeks of randomization. Must have recovered from all side effects.
- •9Flutamide (Eulexin) within 4 weeks of randomization.
- •10Finasteride (Proscar), bicalutamide (Casodex), nilutamide (androne), within 6 weeks of randomization.
- •11Biologic therapy within 4 weeks of randomization
- •12Systemic corticosteroid use within 4 weeks of randomization
- •13History of myocardial infarction or cerebrovascular accident (CVA) within 6 months of randomization
- •14Thrombotic event requiring anti-coagulation therapy within 4 weeks of randomization
- •15History of autoimmune disease such as systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis that was previously treated with cytotoxic agents or systemic steroids
- •16History of another malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage 1 or 2 cancer currently in complete remission or any other cancer that has been in complete remission for at least 5 years
- •17Known hypersensitivity to GM-CSF or to any of the other components of CG1940 and CG8711, which include fetal bovine serum (FBS), DMSO and pentastarch and may include small amounts of dextran sulfate, porcine trypsin and DNase
- •18Known hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80
- •19Known hypersensitivity to prednisone
- •20Previously randomized in this study or CGI protocol G-0029, but never received any study drug.
研究者
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A Phase 3 Randomized, Open-Label Study of Docetaxel in Combination with CG1940 and CG8711 versus Docetaxel and Prednisone in Taxane-Naïve Patients with Metastatic Hormone-Refractory Prostate Cancer With Pain - G-0034EUCTR2005-003275-20-GBCell Genesys Inc.600