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

Phase 2

• Conditions: Brain Metastases; Bevacizumab; Non Squamous Non-small Cell Lung Cancer
• Interventions: Drug: Pemetrexed/cisplatin; Drug: Bevacizumab and Pemetrexed/cisplatin

• Registration Number: NCT01951482
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-09-16
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-26
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-26
• Primary Completion: 2019-12
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Patient who was confirmed stage IV non squamous NSCLC with EGFR wild type and brain metastases by pathologic histology or cytology
2. Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab) after diagnosed brain metastases
3. Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI
4. 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).
5. Patients should be contraceptive during the period of the trial

Exclusion Criteria

1. Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component.
2. History of haemoptysis
3. Evidence of tumour invading major blood vessels on imaging.
4. Patient was received irradiation of brain. Patient with meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid.
5. Previous radiotherapy.
6. Serious uncontrolled coagulation disorder or thrombi-embolic complications within 6 months prior to study start or history of serious bleeding complications.
7. Major surgical procedures within 4 weeks prior to study entry.
8. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
9. Non-healing wound, active peptic ulcer or bone fracture.
10. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pemetrexed/cisplatin	Pemetrexed/cisplatin	Pemetrexed/cisplatin q21d
Bevacizumab and Pemetrexed/cisplatin	Bevacizumab and Pemetrexed/cisplatin	Bevacizumab 7.5mg/kg d1+Pemetrexed/cisplatin q21d

Primary Outcome Measures

Name	Time	Method
Compare iPFS(intracranial progression free survival) in two arms	3 Years

Secondary Outcome Measures

Name	Time	Method
Response rate(CR&PR)	3 years

Trial Locations

Locations (1)

Sun Yat-sen University of Cancer Center; 🇨🇳 Guangzhou, Guangdong, China