Carboplatin and Paclitaxel in Treating Older Patients With Metastatic or Recurrent Unresectable Non-small Cell Lung Cancer
A Phase II Study of Carboplatin and Paclitaxel in Elderly Patients With Metastatic or Recurrent Unresectable Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of carboplatin and paclitaxel in treating patients who have metastatic or recurrent unresectable non-small cell lung cancer.
研究概览
详细说明
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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Arizona
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Scottsdale、Arizona、美国、85259-5404
- CCOP - Scottsdale Oncology Program
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Illinois
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Peoria、Illinois、美国、61602
- CCOP - Illinois Oncology Research Association
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Urbana、Illinois、美国、61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids、Iowa、美国、52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines、Iowa、美国、50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City、Iowa、美国、51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita、Kansas、美国、67214-3882
- CCOP - Wichita
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Michigan
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Ypsilanti、Michigan、美国、48197
- Ann Arbor Hematology Oncology
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Minnesota
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Duluth、Minnesota、美国、55805
- CCOP - Duluth
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Rochester、Minnesota、美国、55905
- Mayo Clinic Cancer Center
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Saint Cloud、Minnesota、美国、56303
- CentraCare Clinic
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Saint Louis Park、Minnesota、美国、55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha、Nebraska、美国、68131
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck、North Dakota、美国、58501
- Quain & Ramstad Clinic, P.C.
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Fargo、North Dakota、美国、58122
- CCOP - Merit Care Hospital
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Ohio
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Toledo、Ohio、美国、43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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South Dakota
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Rapid City、South Dakota、美国、57709
- Rapid City Regional Hospital
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Sioux Falls、South Dakota、美国、57105-1080
- CCOP - Sioux Community Cancer Consortium
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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
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Stage IV disease OR Recurrent unresectable disease No other conventional curative or significant palliative therapies available Measurable disease At least one lesion a minimum of one dimension in diameter of at least 20 mm No symptomatic and/or untreated CNS metastases
PATIENT CHARACTERISTICS: Age: 65 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST no greater than 3 times upper limit of normal Renal: Creatinine clearance at least 40 mL/min Other: No uncontrolled infection No uncontrolled seizure disorder No uncontrolled diabetes mellitus No other malignancies within the past 3 years except adequately treated basal or squamous cell skin cancer or noninvasive carcinomas
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic or immunotherapy for recurrent or metastatic disease No concurrent biologic therapy Chemotherapy: No prior chemotherapy for recurrent or metastatic disease except as radiosensitizer No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for recurrent or metastatic disease except as adjuvant therapy At least 4 weeks since prior radiotherapy to greater than 25% of bone marrow No concurrent radiotherapy except for CNS therapy Surgery: See Disease Characteristics At least 3 weeks since prior major surgery
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 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 |
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实验性的:carboplatin + paclitaxel
Following completion of the Lubben Social Network Scale and Frailty Questionnaire, patients receive carboplatin IV over 30 minutes and paclitaxel IV over 60 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses. Patients with complete response receive 2 additional courses of therapy. Patients with partial response or stable disease may receive additional courses of therapy at investigator's discretion. Patients are followed every 3 months for 5 years or until disease progression. |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
反应速度
大体时间:长达 5 年
|
长达 5 年
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合作者和调查者
出版物和有用的链接
一般刊物
- Jatoi A, Hillman S, Stella P, Green E, Adjei A, Nair S, Perez E, Amin B, Schild SE, Castillo R, Jett JR; North Central Cancer Treatment Group. Should elderly non-small-cell lung cancer patients be offered elderly-specific trials? Results of a pooled analysis from the North Central Cancer Treatment Group. J Clin Oncol. 2005 Dec 20;23(36):9113-9. doi: 10.1200/JCO.2005.03.7465.
- Jatoi A, Hillman S, Stella PJ, Mailliard JA, Sloan J, Vanone S, Cannon MW, Kutteh L, Kanard A, Jett JR. Daily activities: exploring their spectrum and prognostic impact in older, chemotherapy-treated lung cancer patients. Support Care Cancer. 2003 Jul;11(7):460-4. doi: 10.1007/s00520-003-0449-5. Epub 2003 Mar 12.
- Jatoi A, Stella PJ, Hillman S, Mailliard JA, Vanone S, Perez EA, Cannon MW, Geyer S, Wiesenfeld M, Jett JR. Weekly carboplatin and paclitaxel in elderly non-small-cell lung cancer patients (>or=65 years of age): a phase II North Central Cancer Treatment Group study. Am J Clin Oncol. 2003 Oct;26(5):441-7. doi: 10.1097/01.coc.0000027460.53907.38.
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 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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IO BiotechMerck Sharp & Dohme LLC完全的
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