Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III Non-Small Cell Lung Cancer
Phase II Trial of Neoadjuvant Therapy With Carboplatin and Gemcitabine With Thalidomide in Patients With Stage II and IIIA Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and gemcitabine together with thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving carboplatin and gemcitabine together with thalidomide works in treating patients who are undergoing surgery for stage II or stage III non-small cell lung cancer.
研究概览
地位
条件
详细说明
OBJECTIVES:
Primary
- Determine the complete and partial response rates in patients with stage II or IIIA non-small cell lung cancer treated with neoadjuvant carboplatin, gemcitabine hydrochloride, and thalidomide.
Secondary
- Determine, preliminarily, the mechanism of action and activity of thalidomide against lung cancer.
- Determine the 1-year and 2-year survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the operative mortality of patients treated with this regimen.
OUTLINE: This is a pilot study.
Patients receive carboplatin intravenously (IV) over 30 minutes on day 1, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and oral thalidomide once daily on days 1-21. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after the completion of chemotherapy, patients with resectable tumors undergo surgical resection.
After completion of study treatment, patients are followed every 3 months for 2 years.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Minnesota
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Minneapolis、Minnesota、美国、55455
- University of Minnesota Cancer Center
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Robbinsdale、Minnesota、美国、55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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New Hampshire
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Lebanon、New Hampshire、美国、03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologic subtypes:
- Squamous cell carcinoma
- Adenocarcinoma
- Large cell undifferentiated carcinoma
- Stage II or IIIA disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral Computerized Axial Tomography (CT) scan
- No tumor involving the superior sulcus (e.g., Pancoast tumor)
- Karnofsky performance status 70-100%
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 2 mg/dL
- Bilirubin < 2 mg/dL
- Aspartate aminotransferase (AST) < 3 times upper limit of normal
Exclusion Criteria:
Pregnant or nursing
- No nursing during and for ≥ 4 weeks after completion of study treatment
- Positive pregnancy test
- Fertile female patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after completion of study treatment
- Fertile male patients must use effective barrier contraception during and for 4 weeks after completion of study treatment
- Blood, sperm, or ova donation during study treatment
- Post obstructive pneumonia
- Other serious infection or medical illness that would preclude study participation
- Other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other malignancy that is unlikely to affect survival for the next 3 years
- Less than 5 years since prior resection of lung disease
- Prior systemic chemotherapy or radiotherapy for non-small cell lung cancer (NSCLC)
- Other concurrent chemotherapy or radiotherapy
- Concurrent hormonal therapy or immunotherapy
- Other concurrent anticancer therapy
- Other concurrent investigational agents
- Concurrent participation in another clinical study
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Treatment Arm
Chemotherapy treatment (carboplatin, gemcitabine and thalidomide) every 21 days for 3 courses.
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Day 1 of Cycles 1, 2 and 3 - intravenously (IV) 30 minutes (Area Under the Curve = 5.5)
其他名称:
Days 1 and 8 of Cycles 1, 2 and 3 - 30 minute IV, 1000 mg/m2.
其他名称:
Oral administration: Cycle 1 - Day 1 50 mg, Day 2 100 mg, Day 3 150 mg, Day 4 and continuing until end of study treatment 200 mg.
其他名称:
Resection - between 2 and 6 weeks following last dose of chemotherapy.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of Patients Reporting Clinical Response
大体时间:At end of 3 -21 day cycles of treatment
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Objective clinical response measuring using tumor assessments: Complete Response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level, if applicable.
Pathological Complete Response (PCR) = No viable tumor cells in specimen determined by light microscopy.
Partial Response (PR) = at least 30% decrease in the sum of longest diameter of target lesions from baseline.
Progressive Disease (PD) = at least 20% increase in the sum of longest diameters of target lesions from baseline or new lesions.
Stable Disease (SD) = Neither PR or PD.
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At end of 3 -21 day cycles of treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of Patients Disease-free at 1 Year
大体时间:1 year
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Calculated from date of enrollment to date of recurrence or death, whichever came first
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1 year
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Number of Patients Disease-free at 2 Years
大体时间:2 Years
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Calculated from date of enrollment to date of recurrence or death, whichever came first
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2 Years
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Number of Patients Alive at 1 Year (Survival)
大体时间:12 Months
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Participants who were alive at one year from date of enrollment .
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12 Months
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Number of Patients Alive at 2 Years (Survival)
大体时间:24 Months
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Participants who were alive at 2 years from date of enrollment.
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24 Months
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Number of Patients Alive at 56 Months (End of Study)
大体时间:Up to 56 months
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Patients alive from date of enrollment to date of death or censored at date of last contact (Overall Survival).
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Up to 56 months
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合作者和调查者
调查人员
- 学习椅:Arkadiusz Dudek, MD、Masonic Cancer Center, University of Minnesota
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2002LS013
- LILLY-X-382 (其他标识符:Eli Lilly)
- 0202M17981 (其他标识符:IRB, University of Minnesota)
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