Topotecan and Paclitaxel in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
Phase II Trial of Topotecan and Paclitaxel in Previously Treated Patients With Relapsed 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 topotecan and paclitaxel in treating patients who have recurrent or refractory small cell lung cancer.
研究概览
详细说明
OBJECTIVES:
- Determine the toxicity of combination topotecan and paclitaxel in previously treated patients with small cell lung cancer.
- Determine the response rate and survival in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to length of time since prior treatment (less than 3 months (stratum A) vs 3 months or more (stratum B)). Stratum A closed to accrual effective 06/20/2000.
Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on day 3. Courses repeat every 4 weeks.
Patients who achieve partial response or stable disease continue treatment in the absence of complete response or disease progression. Patients who develop disease progression in the CNS only should receive whole brain radiotherapy and then continue treatment. Patients who achieve complete remission receive a maximum of 6 courses of treatment. Patients may then undergo prophylactic cranial irradiation and/or thoracic radiotherapy at the discretion at the attending physician.
Patients are followed every 3 months for 2 years and then at 3 years after study.
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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Saskatchewan
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Regina、Saskatchewan、加拿大、S4T 7T1
- Allan Blair Cancer Centre
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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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Louisiana
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New Orleans、Louisiana、美国、70121
- CCOP - Ochsner
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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 Health Plaza
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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
- Medcenter One Health System
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Grand Forks、North Dakota、美国、58201
- Altru Health Systems
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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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Pennsylvania
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Danville、Pennsylvania、美国、17822-2001
- CCOP - Geisinger Clinic and Medical Center
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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、57104
- 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:
- Stratum A (less than 3 months since prior therapy) closed to accrual effective 06/20/2000)
Histologically or cytologically confirmed recurrent or refractory small cell lung cancer
- Only 1 prior regimen allowed (an alternating regimen with cyclophosphamide/doxorubicin/vincristine and etoposide/cisplatin is acceptable)
- No mixed histology
- Measurable or evaluable disease that has not been in the field of prior radiotherapy
- No uncontrolled CNS metastases (treated CNS metastases eligible)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
- Direct bilirubin normal
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No unstable angina pectoris
- No uncontrolled congestive heart failure
- No myocardial infarction within the past 3 months
Other:
- No uncontrolled infections
- No other concurrent malignancy except skin cancer or localized prostate cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No prior topoisomerase I inhibitor (e.g., topotecan or irinotecan) or taxane (e.g., paclitaxel or docetaxel)
- At least 3 months since other prior chemotherapy
Radiotherapy:
- See Disease Characteristics
- At least 2 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- At least 3 weeks since any 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 |
---|---|
实验性的:topotecan + paclitaxel + radiotherapy
Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on day 3. Courses repeat every 4 weeks. Patients who achieve partial response or stable disease continue treatment in the absence of complete response or disease progression. Patients who develop disease progression in the CNS only should receive whole brain radiotherapy and then continue treatment. Patients who achieve complete remission receive a maximum of 6 courses of treatment. Patients may then undergo prophylactic cranial irradiation and/or thoracic radiotherapy at the discretion at the attending physician. Patients are followed every 3 months for 2 years and then at 3 years after study. |
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
|
次要结果测量
结果测量 |
大体时间 |
---|---|
生存
大体时间:长达 5 年
|
长达 5 年
|
合作者和调查者
出版物和有用的链接
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
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
放射治疗的临床试验
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