NCT00034164已完成2 期
A Phase IIA Multicenter Evaluation of the Safety and Efficacy of Weekly Administration of S-8184 Paclitaxel Injectable Emulsion in Second Line Treatment of Patients With Relapsed Stage IIIB OR IV Non Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To determine the objective response rate
研究概览
简要总结
Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients with relapsed stage IIIB or IV non small cell lung cancer.
详细描述
The goals of this study are to determine the objective response rate, to determine time to disease progression, duration of response, and survival, and to identify the maximum tolerated weekly dose and principal toxicities of S-8184 in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologic diagnosis of non small cell lung cancer
- •Relapsed or unresectable stage IIIB or IV disease
- •One and only one prior cytotoxic chemotherapy regimen which must have included a platinum agent dosed at 60 mg/m2 or higher per cycle for cisplatin and AUC 6 per cycle for carboplatin
- •Documented response of at least stable disease while on first line therapy
- •Adult (18 years of age or older) patients
- •Adequate hematologic function (ANC greater than 1500 cells/mm3 and platelets greater than 100,000/mm3)
- •Serum creatinine less than 2.0 mg/dL
- •Total bilirubin less than 1.5 mg/dL; SGOT and SGPT less than 3 times the upper limit of institutional normal values
- •ECOG performance status of 0 - 2
- •Bidimensional measurable or clinically evaluable disease
- •Patients who have signed an IRB / Ethics Committee approved informed consent
- •Life expectancy at least 12 weeks
- •Patient has fully recovered from any previous surgery (at least 4 weeks since major surgery)
- •Patient has a negative pregnancy test prior to study entry if premenopausal. (Patients of child bearing potential must use a medically effective form of contraception during the treatment.)
排除标准
- •Patients who have received any taxane-containing preparation including Taxol (paclitaxel) or Taxotere (docetaxel)
- •Patients with intracranial metastases having neurologic function stabilized for less than 4 weeks prior to study entry
- •Females who are pregnant or lactating
- •Patients with peripheral neuropathy NCI-CTC grade 2 or greater
- •Patients who have received wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of study entry; or mitomycin or nitrosoureas within 6 weeks of study entry
- •Patients who have had an investigational agent within 4 weeks of study entry
- •Patients receiving concurrent anticonvulsants known to induce P450 isoenzymes
结局指标
主要结局
To determine the objective response rate
时间窗: After all patients completed therapy
次要结局
- To determine time to disease progression(After all patients completed therapy)
研究者
研究点 (1)
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