Pemetrexed/Cisplatin With or Without Bevacizumab in Brain Metastases From Non Squamous Non-small Cell Lung Cancer
Primary Purpose
Non Squamous Non-small Cell Lung Cancer, Brain Metastases, Bevacizumab
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pemetrexed/cisplatin
Bevacizumab and Pemetrexed/cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Non Squamous Non-small Cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
- Sun Yat-sen University of Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bevacizumab and Pemetrexed/cisplatin
Pemetrexed/cisplatin
Arm Description
Bevacizumab 7.5mg/kg d1+Pemetrexed/cisplatin q21d
Pemetrexed/cisplatin q21d
Outcomes
Primary Outcome Measures
Compare iPFS(intracranial progression free survival) in two arms
Secondary Outcome Measures
Response rate(CR&PR)
Full Information
NCT ID
NCT01951482
First Posted
September 16, 2013
Last Updated
October 25, 2017
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT01951482
Brief Title
Pemetrexed/Cisplatin With or Without Bevacizumab in Brain Metastases From Non Squamous Non-small Cell Lung Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Squamous Non-small Cell Lung Cancer, Brain Metastases, Bevacizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab and Pemetrexed/cisplatin
Arm Type
Experimental
Arm Description
Bevacizumab 7.5mg/kg d1+Pemetrexed/cisplatin q21d
Arm Title
Pemetrexed/cisplatin
Arm Type
Active Comparator
Arm Description
Pemetrexed/cisplatin q21d
Intervention Type
Drug
Intervention Name(s)
Pemetrexed/cisplatin
Intervention Description
receive Pemetrexed/cisplatin every 21 days
Intervention Type
Drug
Intervention Name(s)
Bevacizumab and Pemetrexed/cisplatin
Intervention Description
receive Bevacizumab 7.5mg/kg and Pemetrexed/cisplatin every 21 days
Primary Outcome Measure Information:
Title
Compare iPFS(intracranial progression free survival) in two arms
Time Frame
3 Years
Secondary Outcome Measure Information:
Title
Response rate(CR&PR)
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
PFS: progress free survival
Time Frame
3 years
Title
OS: overall survival
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
li-kun hen, Doctor
Phone
13798019964
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
li-kun Chen, Doctor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Sun Yat-sen University of Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
li-kun Chen, doctor
Phone
13798019964
Email
chenlk@sysucc.org.cn
12. IPD Sharing Statement
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Pemetrexed/Cisplatin With or Without Bevacizumab in Brain Metastases From Non Squamous Non-small Cell Lung Cancer
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