EUCTR2005-002738-36-GB进行中（未招募）1 期
A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients with Metastatic Hormone-Refractory Prostate Cancer who are Chemotherapy-Naïve
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
- •1Males greater than 18 years of age
- •2Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
- •3Metastatic 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 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 the discontinuation of any other anti-androgen therapy. The second PSA value must be = 5.0 ng/mL.
- •4Detectable metastases by bone scan, CT scan or MRI
- •5Testosterone < 50 ng/dL (1.73 nmol/L). Must have had orchiectomy or is currently receiving an LHRH agonist/antagonist
- •6WBC = 3,000 cells/mm3, ANC > 1,500 cells/mm3, hemoglobin = 9 g/dL (5.6 mmol/L), and platelets = 100,000 cells/mm3
- •7Serum creatinine < 2.0 mg/dL (177 µmol/L)
- •8Total or direct bilirubin = the upper limit of normal
- •9AST or ALT = 1.5 times the upper limit of normal concomitant with alkaline phosphatase = 2.5 times the upper limit of normal
- •10CD4+ lymphocytes > 200 cells/mm³
- •11ECOG performance status 0-2
- •12Life expectancy of at least 6 months
- •13If sexually active, willing to use barrier contraception while on study drug treatment
- •14The 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
- •2Patients taking any Level 3 (opioid) pain medication at any dose with any frequency are excluded from the study. Patients taking Level 2 (moderate) pain medication who are experiencing cancer related pain are not eligible for the study.
- •3Clinical evidence of brain metastases or history of brain metastases
- •4Third space fluid accumulation, such as ascites or symptomatic pleural effusion
- •5Clinically significant active infection or uncontrolled medical condition considered high-risk for docetaxel, corticosteroids or investigational new drug treatment
- •6Prior gene therapy
- •7Prior chemotherapy or cancer vaccine for prostate cancer. Chemotherapy is defined as taxanes, mitoxantrone, estramustine, etoposide, vinca alkaloids, cyclophosphamide and anthracyclines.
- •8Radiation 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.
- •9Surgery within 4 weeks of randomization. Must have recovered from all side effects.
- •10Flutamide (Eulexin) within 4 weeks of randomization
- •11Finesteride (Proscar), bicalutamide (Casodex), nilutamide (androne), within 6 weeks of randomization
- •12Biologic therapy within 4 weeks of randomization
- •13Systemic corticosteroid use within 4 weeks of randomization
- •14History of myocardial infarction or cerebrovascular accident (CVA) within 6 months of randomization
- •15Thrombotic event requiring anti-coagulation therapy within 4 weeks of randomization
- •16History of autoimmune disease such as systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis that was previously treated with cytotoxic agents or systemic steroids
- •17History of another malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years
- •18Known hypersensitivity to GM-CSF or to any 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
- •19Known hypersensitivity to prednisone
- •20Known hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80
- •21Previously randomized in this study, but never received any study drug
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