Pemetrexed/Cisplatin With or Without Bevacizumab in Brain Metastases From Non Squamous Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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This is a multi-center phase II randomized controlled study to assess the efficacy of Pemetrexed/cisplatin with or without Bevacizumab on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR wild type by intracranial PFS(iPFS),also PFS ,DCR and OS.The side effect is evaluated as well.

Official Title
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Multicenter Phase II Study of Pemetrexed/Cisplatin With or Without Bevacizumab in Patients With Brain Metastases From Non Squamous Non-small Cell Lung Cancer Harboring EGFR Wild Type

Conditions
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Non Squamous Non-small Cell Lung Cancer, Brain Metastases, Bevacizumab

Intervention / Treatment
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* Drug: Pemetrexed/cisplatin
* Drug: Bevacizumab and Pemetrexed/cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who was confirmed stage IV non squamous NSCLC with EGFR wild type and brain metastases by pathologic histology or cytology Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab) after diagnosed brain metastases Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI Adult patients (≥ 18 years and ≤75 years). ECOG Performance Status 0 or 1 Life expectancy of at least 12 weeks.,Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L. Total bilirubin £ 1.5 x upper limit of normal (ULN). ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases. Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula). Patients should be contraceptive during the period of the trial Exclusion Criteria: Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component. History of haemoptysis Evidence of tumour invading major blood vessels on imaging. Patient was received irradiation of brain. Patient with meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid. Previous radiotherapy. Serious uncontrolled coagulation disorder or thrombi-embolic complications within 6 months prior to study start or history of serious bleeding complications. Major surgical procedures within 4 weeks prior to study entry. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion. Non-healing wound, active peptic ulcer or bone fracture. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab and Pemetrexed/cisplatin<br>Bevacizumab 7.5mg/kg d1+Pemetrexed/cisplatin q21d | Drug: Bevacizumab and Pemetrexed/cisplatin<br>* receive Bevacizumab 7.5mg/kg and Pemetrexed/cisplatin every 21 days<br>|
| Active Comparator: Pemetrexed/cisplatin<br>Pemetrexed/cisplatin q21d | Drug: Pemetrexed/cisplatin<br>* receive Pemetrexed/cisplatin every 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare iPFS(intracranial progression free survival) in two arms |  | 3 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate(CR&PR) |  | 3 years |