Status:
COMPLETED
Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Carcinoma, Small Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This multicenter phase II trial is designed to study the unique combination of chemotherapy (irinotecan./carboplatin) and bevacizumab in the extensive-stage setting. This clinical setting seems ideal ...
Detailed Description
Eligible patients will receive 6 courses of irinotecan, carboplatin, and bevacizumab. The interval between chemotherapy courses will be 28 days. If after 6 courses of treatment, patient's response is ...
Eligibility Criteria
Inclusion
- Histologically confirmed small cell lung cancer,extensive stage disease.
- Measurable or evaluable disease
- No previous chemotherapy
- Able to perform activities of daily living with minimal assistance
- Adequate hematological, live and kidney function
- Provide written informed consent
Exclusion
- Limited stage disease
- PEG or G tubes
- Hemoptysis
- Abdominal fistula, perforation, or abscess within the previous 6 months
- Women who are pregnant or lactating
- Proteinuria
- Serious nonhealing wound, ulcer, or bone fracture
- Evidence of bleeding diathesis or coagulopathy
- Uncontrolled or serious cardiovascular disease
- Uncontrolled brain metastasis
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days; Fine needle aspiration within 7 days
- Patients requiring full-dose anticoagulation must be on a stable dosing schedule prior to enrollment
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00294931
Start Date
February 1 2006
End Date
January 1 2009
Last Update
June 28 2010
Active Locations (4)
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1
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
2
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
3
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
4
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023