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Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer

2014年1月8日 更新者：Case Comprehensive Cancer Center

An Open Label, Multicenter, Randomized, Phase III Comparator Study of Oral Topotecan Versus Intravenous Topotecan for Second Line Therapy in Patients With Small Cell Lung Cancer Who Have Relapsed Greater Than or Equal to 90 Days After Completion of First Line Therapy

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if topotecan is more effective given by infusion or by mouth.

PURPOSE: Randomized phase III trial to compare the effectiveness of topotecan given by infusion with that of topotecan given by mouth in treating patients who have small cell lung cancer that has relapsed following previous therapy.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES: I. Compare the response rate, response duration, time to response, time to progression, and survival of patients with relapsed limited or extensive stage small cell lung cancer treated with oral vs intravenous topotecan. II. Compare the qualitative and quantitative toxicities of these treatment regimens in this patient population. III. Compare the quality of life in these patients.

OUTLINE: This is randomized, multicenter study. Patients are stratified according to gender, liver metastases (yes vs no), and duration of response to prior chemotherapy (6 months or less vs greater than 6 months). Patients are randomized to one of two treatment arms. Arm I: Patients receive topotecan IV over 30 minutes on days 1-5. Arm II: Patients receive topotecan orally on days 1-5. Treatment repeats every 3 weeks in the absence of unacceptable toxicity. Patients experiencing complete or partial response continue until progression or for at least 2 courses past maximal response. Patients with stable disease should receive at least 4 courses. Quality of life is assessed Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.

研究类型

介入性

注册 (实际的)

4

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294
        • University of Alabama Comprehensive Cancer Center
    • Arizona
      • Phoenix、Arizona、美国、85012
        • Veterans Affairs Medical Center - Phoenix (Hayden)
    • California
      • Bakersfield、California、美国、93309
        • Comprehensive Blood and Cancer Center
      • Fountain Valley、California、美国、92708
        • Pacific Coast Hematology/Oncology Medical Group
      • La Jolla、California、美国、92037
        • Scripps Clinic
      • Los Angeles、California、美国、90073
        • Veterans Affairs Medical Center - West Los Angeles
      • Poway、California、美国、92064
        • Southwest Cancer Care
      • Sacramento、California、美国、95817
        • University of California Davis Cancer Center
      • San Diego、California、美国、92120
        • Kaiser Permanente-Southern California Permanente Medical Group
      • San Diego、California、美国、92121
        • Sidney Kimmel Cancer Center
    • Colorado
      • Colorado Springs、Colorado、美国、80909
        • Oncology Clinic, P.C.
    • Florida
      • Gainesville、Florida、美国、32610
        • Shands Cancer Center
      • Jacksonville、Florida、美国、32207
        • Baptist Regional Cancer Institute - Jacksonville
      • Miami、Florida、美国、33176
        • Oncology-Hematology Group of South Florida
      • Pensacola、Florida、美国、32522
        • Baptist Hospital- Pensacola
      • Tampa、Florida、美国、33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Augusta、Georgia、美国、30912-3620
        • Medical College of Georgia Hospital and Clinics
    • Illinois
      • Evanston、Illinois、美国、60201
        • Evanston Northwestern Health Care
      • Hines、Illinois、美国、60141
        • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
    • Indiana
      • Indianapolis、Indiana、美国、46219
        • Oncology and Hematology Associates, Inc.
    • Louisiana
      • Lafayette、Louisiana、美国、70506
        • Louisiana Oncology Associates
      • New Orleans、Louisiana、美国、70121
        • Alton Ochsner Medical Foundation Hospital
    • Michigan
      • Detroit、Michigan、美国、48202
        • Henry Ford Hospital
      • Pontiac、Michigan、美国、48341-2985
        • St. Joseph Mercy Hospital
    • Minnesota
      • Saint Louis Park、Minnesota、美国、55416
        • CCOP - Metro-Minnesota
    • Missouri
      • Saint Louis、Missouri、美国、63141
        • St. John's Mercy Medical Center
    • New Jersey
      • Camden、New Jersey、美国、08103
        • Cooper Cancer Institute
      • Livingston、New Jersey、美国、07039
        • St. Barnabas Medical Center
      • Voorhees、New Jersey、美国、08043
        • Cooper Hospital/University Medical Center
    • New Mexico
      • Santa Fe、New Mexico、美国、87505
        • Santa Fe Hematology/Oncology
    • New York
      • Rochester、New York、美国、14621
        • Rochester General Hospital
      • Syracuse、New York、美国、13210
        • State University of New York - Upstate Medical University
    • North Carolina
      • Winston-Salem、North Carolina、美国、27157-1082
        • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
      • Winston-Salem、North Carolina、美国、27103
        • Salem Research
    • Ohio
      • Cleveland、Ohio、美国、44106-5065
        • Ireland Cancer Center
    • Pennsylvania
      • Hershey、Pennsylvania、美国、17033
        • Penn State Geisinger Cancer Center
      • Lemoyne、Pennsylvania、美国、17043-1440
        • Central Pennsylvania Hematology & Medical Oncology Associates, PC
      • Pittsburgh、Pennsylvania、美国、15213
        • University of Pittsburgh Cancer Institute
      • Reading、Pennsylvania、美国、19612-6052
        • Reading Hospital and Medical Center
    • Rhode Island
      • Providence、Rhode Island、美国、02912
        • Brown University Oncology Group
    • South Carolina
      • Greenville、South Carolina、美国、29605
        • Cancer Centers of the Carolinas
      • Spartanburg、South Carolina、美国、29303
        • Spartanburg Regional Healthcare System
    • Tennessee
      • Knoxville、Tennessee、美国、37901
        • Baptist Regional Cancer Center - Knoxville
      • Nashville、Tennessee、美国、37203
        • Sarah Cannon-Minnie Pearl Cancer Center
    • Texas
      • Fort Worth、Texas、美国、76104
        • Texas Cancer Care
      • Galveston、Texas、美国、77555-0209
        • University of Texas Medical Branch
      • Houston、Texas、美国、77030-4009
        • University of Texas - MD Anderson Cancer Center
      • Lubbock、Texas、美国、79410
        • Joe Arrington Cancer Center
      • Temple、Texas、美国、76508
        • Scott and White Memorial Hospital
    • Virginia
      • Norfolk、Virginia、美国、23502
        • Office of Michael E. Lee
      • Richmond、Virginia、美国、23226
        • Hematology & Oncology Associates of Virginia
      • Roanoke、Virginia、美国、24014
        • Oncology and Hematology Associates of Southwest Virginia, Inc.
    • Wisconsin
      • Waukesha、Wisconsin、美国、53188
        • Waukesha Memorial Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed limited or extensive stage small cell lung cancer (SCLC) Disease recurring at least 90 days following completion of first line chemotherapy Partial or complete response to first line therapy Must have at least one bidimensionally measurable non CNS lesion May be within a prior radiation port if at least 6 weeks since prior radiotherapy and progressing Brain and/or leptomeningeal metastases allowed if asymptomatic and not requiring corticosteroids

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL (after transfusion, if needed) Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No active uncontrolled infection No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I low grade prostate cancer No other severe medical conditions that would preclude study or cause exposure to extreme risk or decreased life expectancy No uncontrolled emesis No active peptic ulcer, diabetes mellitus, chronic gastritis, significant ascites, or other gastrointestinal (GI) conditions (e.g., removal of a portion of the stomach or recent GI obstruction) that would alter absorption or GI motility No history of allergic reactions to compounds chemically related to topotecan Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 3 months prior to, during, and at least 4 weeks after the study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior immunotherapy No concurrent immunotherapy for SCLC Chemotherapy: See Disease Characteristics No prior topotecan Only one prior chemotherapy regimen allowed No other concurrent chemotherapy for SCLC Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 24 hours since prior radiotherapy No concurrent radiotherapy for SCLC Surgery: At least 4 weeks since prior surgery Other: At least 30 days or five half lives since other prior investigational drugs No prior drugs (e.g., cisapride) that would alter absorption or GI motility No other concurrent investigational therapy for SCLC

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：单组作业

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Case Comprehensive Cancer Center

合作者

Smith Kline Beecham

调查人员

  • 学习椅：Nathan Levitan, MD、Case Comprehensive Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

1999年3月1日

初级完成 (实际的)

2001年11月1日

研究完成 (实际的)

2001年11月1日

研究注册日期

首次提交

1999年11月1日

首先提交符合 QC 标准的

2004年4月13日

首次发布 (估计)

2004年4月14日

研究记录更新

最后更新发布 (估计)

2014年1月9日

上次提交的符合 QC 标准的更新

2014年1月8日

最后验证

2014年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SKF1598
  • CWRU-SKF-1598
  • SB-104864-A/396
  • NCI-G99-1524

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.

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赞助者和合作者

医疗条件

药物干预

CROs by country

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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