EUCTR2006-005122-23-IT进行中（未招募）不适用
A Phase II/III Randomized, Double-Blind Study of Paclitaxel plus Carboplatin in Combination with Vorinostat (MK-0683) or Placebo in Patients with Stage IIIB (with pleural effusion) or Stage IV Non-Small-Cell Lung Cancer (NSCLC) - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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
- All
入选标准
- •Patients must meet all of the following criteria to participate in the study.
- •1.Patient has a histologically- or cytologically-confirmed diagnosis of Stage IIIB (with pleural effusion) or Stage IV NSCLC.
- •2.Patient has received no prior systemic chemotherapy, with the exception of adjuvant chemotherapy for NSCLC. If the patient has received prior adjuvant chemotherapy for NSCLC, it must have been completed 12 months or more prior to study enrollment.
- •3.Patient is ≥18 years of age at the time informed consent is provided.
- •4.Patient has measurable disease as defined by Sections 3.3.3.2 and 3.3.3.3
- •5.Patient is at least 3 weeks from any prior major surgery or radiation therapy and has adequately recovered from the toxicity and/or complications of these interventions.
- •6.Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 (See Appendix 6.1).
- •7.Patients has adequate organ function as indicated by the following:
- •SystemLaboratory Value
- •Hematological
- •Absolute neutrophil count (ANC)≥1,500/µL
- •Platelets≥100,000/µL
- •Hemoglobin≥9.0g/dL ? without qualifications
- •Serum creatinine, or measured
- •24 hour urine creatinine clearance?≤1.5 times the institutional upper limit of normal (ULN) or 24 hour measured urine creatinine clearance ≥60mL/minute for patients with serum creatinine levels >1.5 times the ULN
- •Serum Total bilirubin≤1.5 times the ULN
- •AST (SGOT) and ALT (SGPT)≤2.5 times the ULN
- •Alkaline phosphatase≤5.0 times the ULN
- •Coagulation
- •Prothrombin time (PT)≤1.2 times the ULN unless the patient is receiving therapeutic anticoagulation.
- •Partial thromboplastin time (PTT)≤1.2 times the ULN unless the patient is receiving therapeutic anticoagulation.
- •? Creatinine clearance should be calculated as outlined in Section 3.2.3.5.6.
- •8.Female patient of childbearing potential has a negative pregnancy test (serum) within 72 hours of study enrollment.
- •9.Patient agrees to: (1) use 2 adequate methods of contraception to prevent pregnancy (either 2 barrier methods or a barrier method plus a hormonal contraceptive method)or (2) abstain from heterosexual activity throughout the study starting with Visit 1
- •10.Patient is available for periodic blood sampling, study related assessments, and appropriate clinical management at the treating institution for the duration of the study.
- •11.Patient or patient?s legal representative has voluntarily agreed to participate by giving 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
- •Patients are excluded from participation in the study if they meet any of the following criteria at Visit 1 through Visit 2. No waivers will be issued.
- •Exclusion Criteria Based on Prior Therapy
- •1.Patient has been treated with any investigational agent for any indication within 4 weeks of study enrollment.
- •2.Patient has an active infection or has received intravenous antibacterial, antiviral, or antifungal medications within 2 weeks prior to enrollment.
- •3.Patient has a prior history of treatment with HDAC inhibitors. Patients who have received valproic acid (VPA) for the treatment of seizures may be enrolled on this study, but must not have received VPA within 30 days of study enrollment.
- •4.Patient is on any systemic steroids for any indication, with doses that have not been stabilized to the equivalent of ≤10 mg/day prednisone during the 4 weeks prior to study enrollment.
- •Exclusion Criteria Based on Medical History
- •5.Patients with untreated brain metastases or carcinomatous meningitis are excluded. However, patients who have stable CNS metastases off corticosteroids, and who are at least 4 weeks from the time of appropriate directed local therapy for CNS disease are eligible for protocol enrollment.
- •6.Patient is unable to take and/or tolerate oral medications on a continuous basis.
- •7.Patient has human immunodeficiency virus (HIV) infection or HIV-related malignancy.
- •8.Patient has active hepatitis A, B or C infection.
- •9.Patient is pregnant or breast-feeding.
- •10.Patient has a known allergy or hypersensitivity to any component of vorinostat or carboplatin.
- •11.Patient has a history of gastrointestinal surgery or other procedure that may in the opinion of the investigator, interfere with the absorption or intake of study drugs.
- •12.Patient has uncontrolled concurrent illness or circumstances that could limit compliance with the study, including but not limited to the following: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric or social conditions that may interfere with patient compliance.
- •13.Patient has preexisting Grade 2 or higher neuropathy.
- •14.Patient has a history of prior malignancy with the exception of cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or other localized malignancy that has undergone potentially curative therapy with no evidence of that disease for five years, and who is deemed to be at low risk for recurrence by his/her treating physician.
- •15.Patient is eligible for treatment with bevacizumab in combination with paclitaxel plus carboplatin and for the given patient, bevacizumab is available and treatment with bevacizumab in combination with paclitaxel plus carboplatin is considered to be the preferred treatment.
研究者
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