Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer
- Conditions
- Carcinoma, Small Cell Lung
- Registration Number
- NCT00294931
- Lead Sponsor
- SCRI Development Innovations, LLC
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method median time to progression
- Secondary Outcome Measures
Name Time Method duration of response overall survival overall toxicity overall response rate
Trial Locations
- Locations (4)
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Tennessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States
Chattanooga Oncology Hematology Associates
🇺🇸Chattanooga, Tennessee, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States