Phase I/II Study of Two Different Schedules of Bortezomib (VELCADE, PS-341) and Pemetrexed (ALIMTA) in Advanced Solid Tumors, With Emphasis on Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Number of Patients With Grade ≥ 3 Toxicity (Phase I)
研究概览
简要总结
RATIONALE: Bortezomib and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with pemetrexed disodium may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of two different schedules of bortezomib when given together with pemetrexed disodium and to see how well they work in treating patients with advanced non-small cell lung cancer or other solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the safety, including dose-limiting toxicities, and feasibility of combining bortezomib with pemetrexed disodium in patients with advanced non-small cell lung cancer (NSCLC) or other solid tumors. (Phase I)
- Determine the response rate in patients with advanced NSCLC treated with this regimen. (Phase II)
Secondary
- Compare the toxicity of 2 different schedules of bortezomib and pemetrexed disodium in patients with advanced solid tumors. (Phase I)
- Determine the maximum tolerated dose (MTD) of bortezomib when administered with pemetrexed disodium in 2 different treatment schedules in these patients. (Phase I)
- Determine, preliminarily, the efficacy of the combination of bortezomib and pemetrexed disodium in patients with advanced solid tumors. (Phase I)
- Assess the overall survival and progression-free survival of these patients. (Phase II)
- Evaluate the frequency and severity of toxicities associated with this regimen. (Phase II)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Patients With Grade ≥ 3 Toxicity (Phase I)
时间窗: First cycle of treatment (3 weeks)
Grade 3/4 toxicity occurring in a patient within 1 cycle.
Number of Patients Experiencing a Dose-limiting Toxicity (Phase I)
时间窗: Up to 36 months
Grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding, requirement for transfusion or lasting \>7 days; febrile neutropenia; grade 3 neutropenia associated with infection; any other grade \>/=3 non-hematologic toxicity considered by the investigator to be related to study drug.
Number of Participants Who Experience Adverse Events (Phase I)
时间窗: Throughout the entire study (up to 36 months).
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 (Phase I).
Number of Patients Who Responded to Study Treatment (Phase II)
时间窗: From start of treatment until disease progression/recurrence.
To determine the response rate of bortezomib in combination with pemetrexed in patients with advanced NSCLC. Response rate was assessed by CT scan. CT scans was performed at baseline and every two cycles (prior to 3rd and 5th cycle). The evaluation of response was based on standard RECIST criteria.
次要结局
- Maximum Tolerated Dose of Bortezomib in Combination With Pemetrexel (Phase I)(Up to 36 months)
- Number of Participants With Response to Therapy as Measured by RECIST (Phase I)(Up to 36 months)
- Analysis of Molecular Determinants in Tumor Samples (Phase II)(Up to 36 months)
- Effect of Bortezomib on Over Expression of NF-kB, BCL-2, and BCL-xL (Phase II)(Up to 36 months)
- Importance of Folate-associated Gene Expression and Response or Outcome (Phase II)(Up to 36 months)
- Number of Participants With Toxicities (Phase II)(Up to 36 months)
- Number of Patients With Toxicity by NCI CTC v3.0 (Phase I)(Up to 36 months)