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

Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01951482
• Other study ID #: NSCLC brain metastasis 02
• Status: Recruiting
• Phase: Phase 2
• First received: September 16, 2013
• Last updated: October 25, 2017
• Start date: June 2013
• Est. completion date: June 2020

Study information

• Verified date: October 2017
• Source: Sun Yat-sen University
• Contact: li-kun hen, Doctor
• Phone: 13798019964
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bevacizumab
• Brain Metastases
• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Metastasis
• Non Squamous Non-small Cell Lung Cancer

Intervention

Drug:
• Pemetrexed/cisplatin
receive Pemetrexed/cisplatin every 21 days
• Bevacizumab and Pemetrexed/cisplatin
receive Bevacizumab 7.5mg/kg and Pemetrexed/cisplatin every 21 days

Locations

Country	Name	City	State
China	Sun Yat-sen University of Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PFS: progress free survival		3 years
Other	OS: overall survival		3 years
Primary	Compare iPFS(intracranial progression free survival) in two arms		3 Years
Secondary	Response rate(CR&PR)		3 years