Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer

Study Overview
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Brief Summary
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In this multicenter trial, we plan to evaluate the feasibility and toxicity of initial treatment with irinotecan/carboplatin/radiation therapy, followed by treatment with bevacizumab, in patients with limited stage small cell lung cancer.

Detailed Description
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Upon determination of eligibility, all patients will be receive: Irinotecan + Carboplatin + Radiation Therapy + Bevacizumab Patients will receive 4 courses of irinotecan/carboplatin. Radiation therapy will begin concurrently with the third course of chemotherapy. The intervals between chemotherapy courses will be 21 days except for the interval between the third and fourth courses (during radiation therapy), which will be 28 days.

Official Title
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Phase II Trial of Concurrent Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab (Avastin) in the Treatment of Patients With Limited Stage Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Irinotecan
* Drug: Carboplatin
* Drug: Bevacizumab
* Radiation: Radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be included in this study, you must meet the following criteria: Small cell lung cancer, confirmed by biopsy. Limited stage disease after standard evaluation. Able to perform activities of daily living without assistance. No previous treatment with chemotherapy, radiation therapy, or biologics. Measurable or evaluable disease Adequate bone marrow, liver and kidney function Able to understand the nature of this study and give written consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age < 18 years History of previous malignancies Women pregnant or lactating History or physical exam evidence of central nervous system disease) Active infection requiring intravenous antibiotics Full-dose anticoagulation or thrombolytic therapy within 10 days Proteinuria. Serious nonhealing wound, ulcer, or bone fracture Evidence if bleeding diathesis or coagulopathy History of heart attack within 6 months. Uncontrolled cardiovascular disease PEG or G-tube History of other serious disease Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10). | Drug: Irinotecan<br>* 50mg/m2 days 1 & 8 each 21-day cycle 1 & 2, 28-day cycle 3 & 4<br>* Other names: Camptosar;Drug: Carboplatin<br>* AUC 5<br>* Other names: Paraplatin;Drug: Bevacizumab<br>* 10mg/kg IV every 2 weeks for 10 doses starting week 16<br>* Other names: Avastin;Radiation: Radiation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) | Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-Year Progression-free Survival (PFS) | Progression-free survival (PFS) was defined as the date of study entry until the date of tumor progression or death. 2-Year PFS is the percentage of patients alive and without progressive disease (PD) 2 years from the date of study entry. | 24 months | 
| Overall Response Rate | Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. | 18 month |