NCT00723957已完成2 期
A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-small Cell Lung Cancer
R-Pharm3 个研究点 分布在 2 个国家目标入组 260 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 3
- 主要终点
- Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors
研究概览
简要总结
The purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed non-small cell lung cancer (NSCLC)(squamous cell, adenocarcinoma, large cell, or bronchoalveolar carcinoma)
- •Stage IIIB NSCLC with pleural effusion, Stage IV NSCLC, or recurrent disease following surgery with or without radiation therapy
- •Available paraffin-embedded tissue to measure the expression levels of βIII tubulin
- •Disease measurable by Response Evaluation Criteria in Solid Tumors, with at least 1 target lesion situated outside any previous radiotherapy field
- •Karnofsky performance status of 70-100
- •Life expectancy of at least 3 months
- •Men and women, ages 18 years and older
排除标准
- •Uncontrolled brain metastases
- •Peripheral neuropathy greater than Grade 1
- •Fewer than 4 weeks from prior radiation therapy or locoregional surgeries to randomization date (less than 1 week from focal/palliative radiotherapy or minor surgery)
- •Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
- •Known HIV-positive status
- •Absolute neutrophil count lower than 1500 cells mm^3
- •Total bilirubin level higher than upper limit of normal (ULN) as defined by the institution (with the exception of elevation due to Gilbert's syndrome)
- •Aspartate transaminase or alanine transaminase level higher than 2.5*ULN
- •Serum creatine level of 1.5 mg/dL or higher
- •Renal function with a creatinine clearance of less than 50 mL/min (as calculated with the Cockcroft and Gault equation)
- •Any prior antineoplastic systemic regimens.
研究组 & 干预措施
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)
Experimental
干预措施: Ixabepilone, 32 mg/m^2 (Drug)
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)
Experimental
干预措施: Carboplatin (area under the concentration curve [AUC] 6) (Drug)
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
Active Comparator
干预措施: Paclitaxel, 200 mg/m^2 (Drug)
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
Active Comparator
干预措施: Carboplatin (area under the concentration curve [AUC] 6) (Drug)
结局指标
主要结局
Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors
时间窗: Randomization to disease progression or death (maximum reached: 14.39 months )
Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on-study tumor assessment, progression-free survival was censored at the date of randomization. A tumor was considered to be beta III (βIII)-tubulin positive if 50% or more of the tumor cells had a βIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control.
次要结局
- Time to Response(Randomization to date of first response (PR or CR))
- Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy(Days 1 through 21, continuously)
- Median Length of Survival in the Overall Population and in the Subgroups of Patients With βIII-tubulin Positive (β3T+) and βIII-tubulin Negative (β3T-)Tumors(Randomization to death or last known alive date, up to 31.34 months)
- Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR)(At randomization and then every 6 weeks to date of CR, PR, or progression for 6 21-day cycles)
- Progression-free Survival in the Overall Population(Randomization to disease progression or death, assessed to 12.29 months)
- Progression-free Survival in the Subgroup of Participants With βIII-tubulin Negative Tumors(Randomization to disease progression or death (maximum reached: 12.29 months))
- Number of Participants With Hematology Laboratory Results of Grade 3 or 4(At screening and weekly during 21-day cycle)
- Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results(At screening and within 72 hours of start of 21-day cycle (Cycle 2 and beyond))
研究者
研究点 (3)
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