NCT00437749终止3 期
Phase 3, Randomized, Double-Blind, Placebo-controlled Study of CBT-1 and Paclitaxel/Carboplatin in Patients With Inoperable Non-Small Cell Lung Cancer
CBA Research1 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2001年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
Multiple Drug Resistance is the phenomena whereby cells become resistant to a variety of drugs with different mechanisms of action. Drug resistance remains a significant impediment to successful cancer chemotherapy inhibitors have been developed and are currently in clinical trials. CBT-1 is a natural product currently in clinical trials as an inhibitor
详细描述
Lung cancer has the highest incidence and prevalence among cancers in the world and remains the leading cause of cancer-related deaths in Western countries. One-year survival of patients with best supportive care remains low. Non-small-cell lung cancer accounts for almost 85% of all lung cancer cases. Approximately 70% of patients have locally advanced or metastatic disease at presentation and are not candidates for surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histological confirmed diagnosis of NSCLC
- •advanced inoperable NSCLC
- •have adequate renal function, serum creatinine <2.0 mg/dL or 24 hour creatinine clearance > 50mL/minute
- •have adequate liver function defined as SGOT <4 times the upper limit of normal (ULN) and bilirubin <2.0 mg/dL
- •have calcium <11.0 mg/dL and albumin >2.0g/dL
- •have adequate bone marrow reserve defined as granulocyte count >1,500/mm3, hemoglobin >10.0 g/dL and platelets >100,000/mm3
- •if female and of child-bearing potential, agree to use one of the following methods of birth control: oral contraceptives, barrier with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, complete abstinence from sexual intercourse
排除标准
- •have previously received taxanes, platinums, vinca alkaloids, anthracyclines, epipodophyllotoxins or CBT-1
- •have known or suspected hypersensitivity to platinum containing compounds, taxanes, polyoxyethylated castor oil, or mannitol
- •have significant central nervous system disease, including history of seizures within last 3 months or psychiatric history which would impair the ability to give informed consent or prevent compliance with protocol requirements
- •be eligible for curative surgery or radiotherapy.
- •must not have a diagnosis and/or treatment in the past 5 years of any malignancy other than NSCLC or basal cell carcinoma of the skin
- •be pregnant or nursing
- •have a history of significant coronary artery disease, cardiac arrhythmias requiring treatment, history of other cardiac disease or other cardiac anomalies determined by ECG which in the judgment of the investigator would compromise the patient's ability to tolerate the therapy
- •have ongoing serious infections that require parenteral antibiotics
- •have clinically significant bleeding disorders
- •have solid organ allograft
- •have significant intercurrent disease
- •have bleeding peptic ulcer disease
- •have participated in any experimental study within 2 months preceding enrollment
- •be using a medication that could interact adversely with CBT-1, paclitaxel, or carboplatin. Medications include:aminoglycoside antibiotics, Prilosec, Losec, Zantac
研究组 & 干预措施
CBT-1
Active Comparator
干预措施: CBT-1 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Overall Survival
时间窗: every month for first 6 months off study, then every 2-3 months for the next year, then every 6 months thereafter
次要结局
- Time to Progression(each month for the first 6 months off study, then every 2-3 months for the next year, then every 6 months thereafter.)
- Response Rates(every 2-3 months following completion of therapy until disease progression)
- Progression Free Survival(every month for first 6 months off study, then every 2-3 months for next year, then every 6 months thereafter.)
研究者
研究点 (1)
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