NCT00269828终止3 期
Paclitaxel Poliglumex (CT-2103) vs. Paclitaxel for the Treatment of Women With Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) Who Are Performance Status 2.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 600
- 试验地点
- 285
- 主要终点
- The primary objective of this study is to compare the overall survival of female patients randomized to CT-2103 to that of female patients randomized to paclitaxel.
研究概览
简要总结
This is a randomized, open-label, multinational, phase III study in women with histologically- or cytologically-confirmed advanced NSCLC who are chemotherapy naïve and have PS 2. Study drug will be administered on day 1 of each 21 day cycle
详细描述
See Summary
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
- •Histologically- or cytologically-confirmed diagnosis of NSCLC.
- •ECOG performance score of
- •Patients who meet one of the following criteria:
- •Stage IIIB who are not candidates for combined modality therapy (primary radiation therapy or surgery), or
- •Stage IV.
- •Age greater than or equal to 18 years.
- •Adequate bone marrow function
- •Adequate renal function
- •Adequate hepatic function
- •Patients with known brain metastases must have received standard antitumor treatment for their CNS metastases as defined by the site's institutional standards.
- •Patients who have had major surgery must be fully recovered from the surgery.
- •Ability to comply with the visit schedule and assessments required by the protocol.
- •For patients of reproductive potential, commitment to use adequate contraception.
- •Signed approved informed consent, with understanding of study procedures.
- •Agreement to begin study therapy within 8 calendar days after randomization.
排除标准
- •Any intolerance to poly-L-glutamic acid, Poloxamer 188, dibasic sodium phosphate, monobasic sodium phosphate (the excipients of CT-2103).
- •Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology.
- •Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent.
- •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. (If unstable neurologic symptoms resulted from brain metastases, patient must meet inclusion criteria number 9).
- •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. Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status is stable.
- •Pregnant women or nursing mothers.
- •Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.
结局指标
主要结局
The primary objective of this study is to compare the overall survival of female patients randomized to CT-2103 to that of female patients randomized to paclitaxel.
次要结局
- Secondary objectives are to compare the progression-free survival, response rate, disease control, clinical benefit, quality of life, and the safety and tolerability of the treatment arms.
研究者
研究点 (285)
Loading locations...
相似试验
撤回
3 期
CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mLNSCLCNCT00576225CTI BioPharma
终止
3 期
CAELYX Versus Paclitaxel HCl in Patients With Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based ChemotherapyOvarian NeoplasmsNCT00653952Johnson & Johnson Pharmaceutical Research & Development, L.L.C.220
已完成
3 期
Trial of TP Versus TC Regimens for Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)Uterine Cervical NeoplasmsNCT00295789Haruhiko Fukuda253
已完成
3 期
Study Comparing Paclitaxel Plus Carboplatin Versus Anthracyclines Followed by Docetaxel as Adjuvant Chemotherapy for Triple Negative Breast Cancer (PATTERN)Breast CancerNCT04031703Fudan University647
终止
不适用
A phase III clinical study to compare paclitaxel (Genexol®-PM) in combination with standard therapy (gemcitabine/cisplatin) and standard therapy alone (gemcitabine/cisplatin) in patients with advanced biliary tractNeoplasmsKCT0003726Asan Medical Center220