NCT00516100Unknown1 期
Phase I/II Clinical Trial of Bortezomib (Velcade) + Pemetrexed (Alimta) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
Aptium Oncology Research Network8 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2006年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 62
- 试验地点
- 8
- 主要终点
- (Phase I)Maximum tolerated dose of bortezomib
研究概览
简要总结
Pemetrexed is an FDA-approved treatment for advanced lung cancer but the response rate is still very low. Bortezomib is currently approved to treat myeloma in patients who have already been treated. Currently, multiple studies are actively investigating how well bortezomib works with other drugs. This study is testing how much bortezomib can be given to advanced lung cancer patients who have already received one treatment. This study will also see how well bortezomib and pemetrexed work together to treat lung cancer patients.
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
- •Unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC who have received one prior platinum-based chemotherapy regimen.
- •One prior treatment with any biologically targeted agent is acceptable
- •Stable, previously treated, brain metastases are allowed if clinically stable without steroid treatment for 10 days.
- •ECOG performance status of 0 or
- •Measurable and/or evaluable indicator lesion(s).
- •Adequate hematologic, renal and hepatic function
- •Patient is of a legally consenting age
- •Patient has a life-expectancy >2 months.
- •Voluntary written informed consent before performance of any study-related procedure
- •Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control for the duration of the study.
- •Male patient agrees to use an acceptable method for contraception for the duration of the study.
排除标准
- •Prior treatment with pemetrexed (Alimta) or Bortezomib (Velcade).
- •Patient was treated for another cancer within 3 years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.
- •Peripheral neuropathy NCI grade >
- •Symptomatic or uncontrolled brain metastasis.
- •Radiation therapy to major bone marrow (> 10% of bone marrow) areas or to target lesions within 30 days prior to study entry.
- •Patient has received other investigational drugs with 14 days before enrollment.
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- •Any systemic therapy within 21 days prior to study entry.
- •Patient known to be human immunodeficiency virus (HIV)-positive.
- •Patient had a significant cardiac event within 6 months of enrollment
- •History of arrhythmia
- •Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.
- •QT prolongation with other medications that required discontinuation of that medication.
- •Presence of left bundle branch block (LBBB).
- •QTc ≥480 msec or greater on screening ECG.
- •Patient has hypersensitivity to bortezomib, boron or mannitol.
- •Female patient is pregnant or breast-feeding.
结局指标
主要结局
(Phase I)Maximum tolerated dose of bortezomib
时间窗: Within 6 three-week cycles (18 weeks)
(Phase II)determine response rate, time to progression, one-year survival, and overall survival rates
时间窗: one year
次要结局
未报告次要终点
研究者
研究点 (8)
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