NCT00294931
Completed
Phase 2
A Phase II Trial of Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer
ConditionsCarcinoma, Small Cell Lung
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Carcinoma, Small Cell Lung
- Sponsor
- SCRI Development Innovations, LLC
- Enrollment
- 50
- Locations
- 4
- Primary Endpoint
- median time to progression
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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 for evaluation of the role of bevacizumab in delaying progression and prolonging survival.
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 a CR/PR/SD they will continue on Bevacizumab until tumor progression or up to 6 cycles (6 months) total. Treatment sequence: * Irinotecan 60mg/m2 on days 1, 8, and 15 * Carboplatin AUC=4 day 1 only * Bevacizumab 10 mg/kg days 1 and 15
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
median time to progression
Secondary Outcomes
- duration of response
- overall survival
- overall toxicity
- overall response rate
Study Sites (4)
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