EUCTR2014-000175-43-IT进行中（未招募）不适用
CHemotherapy plus Enzalutamide In first line therapy for castration Resistant prOstate caNcerA multicentric Randomized phase II study.Ch.E.I.R.O.N. Trial - Ch.E.I.R.O.N. Trial
AZIENDA PROVINCIALE PER I SERVIZI SANITARI DELLA PROVINCIA AUTONOMA DI TRENTO0 个研究点开始时间: 2014年6月20日最近更新:
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试验速览
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
- •Patients meeting all of the following criteria will be considered for enrollment into the study:
- •1.Histologically- or cytologically-confirmed prostate adenocarcinoma.
- •2.Metastatic disease.
- •3.Progressive disease while receiving hormonal therapy or after surgical castration documented by at least one of the following:
- •a.Increase in measurable disease (RECIST 1.1) [15], and/or
- •b.Appearance of new lesions, including those on bone scan (=2 new lesions on 2 consecutive bone scans if progression disease diagnosed on bone scan only) consistent with progressive prostate cancer, and/or
- •c.Rising PSA defined as 2 sequential increases above a previous lowest reference value. Each value must be obtained at least 1 week apart. A PSA value of at least 2 ng/ml is required at study entry.
- •d.Effective castration (serum testosterone levels =0.50 ng/dL) by orchiectomy and/or LHRH agonists or antagonist with or without anti-androgens.
- •i.If the patient has been treated with LHRH agonists or antagonist (i.e., without orchiectomy), then this therapy should be continued.
- •ii.If patients were either started on complete androgen blockade, or had a PSA response (defined by any reduction in PSA sustained for at least 3 months) after adding an antiandrogen, prior anti-androgen therapy should be stopped before randomization: at least 6 weeks for bicalutamide and nilutamide, and at least 4 weeks for flutamide, megestrol acetate and any other hormonal therapy.
- •4.More than 18 years.
- •5.Eastern Cooperative Oncology Group (ECOG) performance status <2 (see Appendix 2).
- •6.Ability to fill the quality of life questionnaire
- •7.Patient compliance and geographic proximity that allow adequate follow-up.
- •8.Presence of signed and dated IRB-approved patient informed consent form prior to enrollment into the study.
- •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 232
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 232
排除标准
- •Patients who have met all the above inclusion criteria listed in Section 4.2. will be screened for the following exclusion criteria:
- •1.Prior chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed >3 years ago.
- •2.Prior treatment with abiraterone acetate and/or enzalutamide
- •3.Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or surgery to the time of randomization. Patients may be on biphosphonates prior to study entry.
- •4.Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow.
- •5.History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
- •6.History of seizure or any condition that may predispose to seizure (eg, prior cortical stroke or significant brain trauma). History of loss of consciousness or transient ischemic attack within 12 months of randomization;
- •7.Inadequate organ and bone marrow function as evidenced by:
- •a.Hemoglobin <10.0 g/dL
- •b.Absolute neutrophil count <1.5 x 109/L,
- •c.Platelet count <100 x 109/L,
- •d.AST and/or ALT >1.5 x ULN;
- •e.Total bilirubin >1.5 x ULN,
- •f.Serum Creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated either according to Cockcroft-Gault formula. Creatinine clearance <60 mL/min will exclude the patient (see Appendix 3 for calculation formula)
- •8.Contraindications to the use of corticosteroid treatment.
- •9.Clinically significant cardiovascular disease including the following:
- •a.Myocardial infarction within 6 months before screening;
- •b.Uncontrolled angina within 3 months before screening;
- •c.Congestive heart failure New York Heart Association class 3 or 4, or a history of congestive heart failure New York Heart Association class 3 or 4, unless a screening echocardiogram or multigated acquisition scan performed within 3 months before randomization demonstrates a left ventricular ejection fraction = 50%;
- •d.History of clinically significant ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes);
- •e.History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place;
- •f.Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mm Hg) at screening;
- •g.Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening electrocardiogram (ECG) and on physical examination;
- •h.Uncontrolled hypertension as indicated by systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening.
- •10.Any of the following within 3 months prior to randomization: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.
- •11.Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
- •12.Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which chemotherapy has been completed >5 years ago and from which the patient has been disease-free for >5 years.
- •13.Participation in another clinical trial and any concurrent treatment with any investigational
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