Clinical trial NCT01951482: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non Squamous Non-small Cell Lung Cancer
Brain Metastases
Bevacizumab
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-09-26
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Compare iPFS(intracranial progression free survival) in two arms
timeFrame: 3 Years
Secondary outcomes:
measure: Response rate(CR&PR)
timeFrame: 3 years
Other outcomes:
measure: PFS: progress free survival
timeFrame: 3 years
measure: OS: overall survival
timeFrame: 3 years
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University of Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: li-kun Chen, Doctor
role: STUDY_DIRECTOR
References: