Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer
NCT ID: NCT00305942
Last Updated: 2013-01-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
61 participants
INTERVENTIONAL
2006-03-31
2009-11-30
Brief Summary
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Detailed Description
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Topotecan 4mg/m2 IV on days 1, 8.
Carboplatin AUC=5 IV day 1 only .
\- Cycles are repeated every 21 days for \> 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Topotecan 4mg/m2 IV on days 1, 8.
Carboplatin AUC=5 IV day 1 only .
\- Cycles are repeated every 21 days for \> 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
Topotecan
Topotecan 4mg/m2 IV on days 1, 8.
carboplatin
Carboplatin AUC=5 IV day 1 only .
Interventions
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Topotecan
Topotecan 4mg/m2 IV on days 1, 8.
carboplatin
Carboplatin AUC=5 IV day 1 only .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with small cell histology are eligible. Large neuroendocrine or mixed small cell and non-small cell histology are not eligible.
* Patients must have measurable or evaluable disease.
* ECOG performance status 0 or 1.
* Patients must have adequate bone marrow, liver and kidney function
* The patients may have had no previous chemotherapy.
* Patients must be able to understand the nature of the study and give written informed consent.
Exclusion Criteria
* Age \< 18 years old.
* History of a prior malignancy within three years with the exception of skin cancer (excluding melanoma), cervical carcinoma in situ, in situ breast carcinoma or stage A/B prostate cancer.
* Female patients who are pregnant or are breast feeding
* History of acute myocardial infarction or stroke within 6 months.
* Uncontrolled hypertension, unstable angina, New York Heart Association grade II or greater CHF, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease.
* Patients who have received other investigational drugs within 28 days.
* Patients with CNS involvement (brain or meningeal). The single exception to this is the patient previously treated for brain metastases with radiation therapy, or surgical excision who has no evidence of active residual metastases on brain MRI at the time of study entry.
* Patients with large neuroendocrine tumor or mixed small cell and non-small cell histology
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 Alabama Regional Medical Center
Anniston, Alabama, United States
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
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Hematology Oncology Life Center
Alexandria, Louisiana, United States
Mercy Hospital
Portland, Maine, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Montana Cancer Institute Foundation
Missoula, Montana, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Associates in Hematology Oncology
Chattanooga, Tennessee, United States
Family Cancer Center
Collierville, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Countries
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References
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Spigel DR, Hainsworth JD, Gandhi JG, Gian VG, Peyton JD, West-Osterfield K, Clark BL, Vazquez ER, Jones SF, Burris HA, Greco FA. A phase II trial of carboplatin and weekly topotecan in the first-line treatment of patients with extensive stage small cell lung cancer. J Thorac Oncol. 2010 Jun;5(6):862-6. doi: 10.1097/jto.0b013e3181d86a4f.
Related Links
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Published article in the Journal of Thoracic Oncology
Other Identifiers
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SCRI LUN 117
Identifier Type: -
Identifier Source: org_study_id
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