Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
NCT ID: NCT00294190
Last Updated: 2012-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2006-02-28
2009-07-31
Brief Summary
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Detailed Description
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Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break. Cycles are repeated every 8 weeks, for 3 cycles. Restaging studies will be performed every cycle (or 8 weeks.)
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Topotecan
Topotecan
Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break.
Interventions
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Topotecan
Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable or evaluable disease
* Able to perform activities of daily living with minimal assistance
* Adequate bone marrow, liver and kidney function
* May have received no more than 3 previous courses of radiation therapy
* Give written informed consent prior to study entry
Exclusion Criteria
* History of a prior malignancy within three years
* Female patients who are pregnant or are breast feeding
* Significant history of uncontrolled cardiac disease
* Myocardial infarction or stroke within six months
* Symptomatic peripheral vascular disease
* CNS involvement
* Serious active infection or underlying medical condition
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
SCRI Development Innovations, LLC
OTHER
Responsible Party
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Principal Investigators
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David R. Spigel, MD
Role: PRINCIPAL_INVESTIGATOR
SCRI Development Innovations, LLC
Locations
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Northeast Arkansas Clinic
Jonesboro, Arkansas, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Hematology Oncology Life Center
Alexandria, Louisiana, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Methodist Cancer Center
Omaha, Nebraska, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Countries
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References
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Spigel DR, Greco FA, Burris HA 3rd, Shipley DL, Clark BL, Whorf RC, Arrowsmith ER, Hainsworth JD. A phase II study of higher dose weekly topotecan in relapsed small-cell lung cancer. Clin Lung Cancer. 2011 May;12(3):187-91. doi: 10.1016/j.cllc.2011.03.016. Epub 2011 Apr 28.
Other Identifiers
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105642
Identifier Type: -
Identifier Source: secondary_id
SCRI LUN 120
Identifier Type: -
Identifier Source: org_study_id