Status:
COMPLETED
Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Small Cell Lung Cancer
Carcinoma, Small Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This proposed phase II trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added ...
Detailed Description
All patients will receive weekly topotecan. 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 per...
Eligibility Criteria
Inclusion
- Extensive small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen
- 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
- Patients with limited stage disease
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00294190
Start Date
February 1 2006
End Date
July 1 2009
Last Update
December 10 2012
Active Locations (13)
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1
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States, 72401
2
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
3
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States, 33805
4
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804