NCT00251446已完成2 期
A Phase II Single Arm Trial of Single-agent Vinflunine as Second-line Treatment of Advanced 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
- 70
- 试验地点
- 2
- 主要终点
- To determine the 1-year survival rate in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.
研究概览
简要总结
This is a Phase II, single-arm study in patients with stage IIIB (with malignant pleural effusion) and IV NSCLC who have been previously treated with a platinum-based doublet.
Each cycle will be 21 days. On Day 1 of each cycle, patients will receive vinflunine 320 mg/m2 as a 20-minute IV infusion.
Patients will continue to receive study treatment until disease progression or unacceptable toxicity.
Patients will be evaluated every 2 cycles for response using RECIST criteria.
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
- •To be eligible for the study, patients must fulfill all of the following criteria:
- •Patients must have signed an IRB-approved informed consent.
- •Patients must have recurrent or metastatic stage IIIB (with malignant pleural effusion) and IV NSCLC that has progressed after receiving a platinum-based doublet as first-line therapy.
- •Patients must have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Previously irradiated lesions will not be allowed as measurable disease.
- •Patients must have an ECOG Performance Status of 0, 1, or
- •Patients must be <18 years of age.
- •Previous chemotherapy must have been completed at least 4 weeks prior to enrollment.
- •Patients must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal for at least 12 months.
- •Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for a reasonable time thereafter.
- •Patients must have an absolute neutrophil count (ANC) >1500/uL, platelet count >100,000/uL, and hemoglobin >8 g/dL.
- •Patients must have a serum creatinine <2 x institutional upper limit of normal (ULN).
- •Patients must have a total bilirubin <2.5 x ULN and aspartate transaminase (AST) <5.0 x ULN.
排除标准
- •Any of the following criteria will make the patient ineligible to participate in this study:
- •Patients previously treated with vinflunine or another vinca alkaloid.
- •Patients with untreated and clinically unstable brain metastases.
- •Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
- •Patients with a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
- •Patient has a co-existing malignancy or had a malignancy diagnosed within the last 3 years, with the exception of basal cell carcinoma or cervical cancer in situ.
- •Patient received treatment with a non-approved or investigational drug within 30 days before planned start of study treatment.
- •Patient is not completely healed from a previous oncologic or other major surgery.
- •Patient is receiving or planning to receive any concurrent chemotherapy not indicated in the study protocol or an investigational agent during the study period.
- •Patients who have a history of hypersensitivity to vinflunine or any of the components in vinflunine or another vinca alkaloid.
- •Any patient who is pregnant or lactating.
- •Any patient who is unable to comply with requirements of study.
结局指标
主要结局
To determine the 1-year survival rate in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.
时间窗: unk
次要结局
- To assess response rate (RR) of single-agent vinflunine in patients with stage IIIB-IV NSCLC who were previously treated with a platinum-based doublet.(unk)
- To assess overall survival in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.(unk)
- To determine the progression-free survival (PFS) in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet(unk)
- To assess time to response (TTR) in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.(unk)
- To assess duration of overall response in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.(unk)
- To assess duration of stable disease in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.(unk)
- To assess the safety of single-agent vinflunine in patients with stage IIIB-IV NSCLC who were previously treated with a platinum-based doublet.(unk)
研究者
研究点 (2)
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