Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Study Overview
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Brief Summary
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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
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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

Official Title
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A Phase II Trial of Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Conditions
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Carcinoma, Small Cell Lung

Intervention / Treatment
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* Drug: irinotecan
* Drug: carboplatin
* Drug: bevacizumab


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: irinotecan|nan|
|Drug: carboplatin|nan|
|Drug: bevacizumab|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median time to progression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall toxicity |  |  | 
| overall response rate |  |  | 
| duration of response |  |  | 
| overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, Small Cell, Extensive