Status:
COMPLETED
Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Carcinoma, Small Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This proposed phase II trial will investigate the combination of topotecan/carboplatin in the first-line treatment of patients with extensive-stage SCLC. Topotecan/platinum regimens are emerging as co...
Detailed Description
Eligible patients will receive treatment with carboplatin and topotecan. 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 ...
Eligibility Criteria
Inclusion
- Patients must have confirmed small cell lung cancer with extensive stage disease. This includes patients with stage IIIB and IV disease.
- 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
- Patients with limited stage disease. This includes IA, IB, IIA, IIB, and IIIA.
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00305942
Start Date
March 1 2006
End Date
November 1 2009
Last Update
January 31 2013
Active Locations (16)
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1
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States, 36207
2
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States, 72401
3
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
4
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States, 33805