Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma

Study Overview
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Brief Summary
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The prognosis of patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) is poor. Chemoradiotherapy is the main treatment modality for this disease. The newer drug regimens can be expected to improve survival in this subset of NSCLC patients. Modern targeted therapies have enhanced the outcomes of lung cancer treatment, especially for advanced NSCLC. Among the targeted approaches for the inhibition of angiogenesis is bevacizumab, a monoclonal antibody that represses vascular endothelial growth factor (VEGF). Bevacizumab in combination with platinum-based chemotherapy used as neoadjuvant chemotherapy may change the previous treatment modality. It allows some lung cancer patients to be downstaged to surgery rather than radiotherapy. Thus, survival of these patients may be improved.

Detailed Description
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This trial investigates the role of neoadjuvant pemetrexed, carboplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma.

Official Title
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A Phase II Study of Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Neoadjuvant Bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed unresectable, locally advanced (III A (bulky N2), III B) lung adenocarcinoma No previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer Adequate organ and bone marrow function Exclusion Criteria: Prior chemotherapy or radiation therapy for NSCLC Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF) Patients with known hypersensitivity to other recombinant human antibodies History of stroke or transient ischemic attack (TIA). History of myocardial infarction or unstable angina within the past 12 months. Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection. Women who are pregnant or breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Neoadjuvant Bevacizumab<br>Four cycles of neoadjuvant chemotherapy with pemetrexed, carboplatin and bevacizumab. | Drug: Neoadjuvant Bevacizumab<br>* Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab followed by surgical resection<br>* Other names: Bevacizumab (Avastin);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resectability rate |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with perioperative complications |  | 4 months | 
| Disease-free survival |  | 2 years | 
| Overall survival |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, lung adenocarcinoma, bevacizumab, adjuvant chemotherapy, surgical resection rate, safety, feasibility