NCT00576225撤回3 期
Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women With Estradiol > 25 pg/mL
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 44
- 主要终点
- Survival
研究概览
简要总结
This study is designed to test whether CT-2103/carboplatin provides improved overall survival compared to paclitaxel/carboplatin in women with NSCLC who have estradiol levels >30 pg/ml.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with baseline estradiol >25 pg/mL
- •Histologically- or cytologically-confirmed diagnosis of NSCLC.
- •ECOG performance score (PS) of 0, 1, or
- •Patients must meet one of the following criteria have either (1) Recurrent disease following completion of radiation or surgery, (2) Stage IIIB disease and not be a candidate for combined modality therapy (primary radiation therapy or surgery), or (3) Stage IV disease.
- •At least 18 years of age.
- •Adequate bone marrow function
- •Adequate renal function
- •Adequate hepatic function
- •Life expectancy ≥12 weeks
排除标准
- •Known hypersensitivity to the excipients or the study drug (either CT-2103, paclitaxel, or carboplatin that the patient will receive.
- •Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology.
- •Weight loss >10% in previous 6 months
- •LDH > 2.5X IULN
- •Both LDH > 1.5X IULN and ≥ 5% weight loss in previous 6 months
- •Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent.
- •Local palliative radiotherapy < 7 days before randomization.
- •Radiation with curative intent < 30 days before randomization.
- •Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer.
- •Grade 2 or greater neuropathy.
- •Evidence of significant unstable neurological symptoms within the 4 weeks before study randomization.
- •Clinically significant active infection for which active therapy is underway.
- •Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent.
- •Unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization.
- •Pregnant women or nursing mothers.
研究组 & 干预措施
Experimental
Experimental
干预措施: CT-2103/carboplatin (Drug)
Control
Active Comparator
干预措施: paclitaxel/carboplatin (Drug)
结局指标
主要结局
Survival
时间窗: up to 3 years post treatment
次要结局
- progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety(up to 3 years post treatment)
研究者
研究点 (44)
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