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Trial Title:
Pemetrexed/Cisplatin With or Without Bevacizumab in Brain Metastases From Non Squamous Non-small Cell Lung Cancer
NCT ID:
NCT01951482
Condition:
Non Squamous Non-small Cell Lung Cancer
Brain Metastases
Bevacizumab
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Brain Neoplasms
Bevacizumab
Cisplatin
Pemetrexed
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pemetrexed/cisplatin
Description:
receive Pemetrexed/cisplatin every 21 days
Arm group label:
Pemetrexed/cisplatin
Intervention type:
Drug
Intervention name:
Bevacizumab and Pemetrexed/cisplatin
Description:
receive Bevacizumab 7.5mg/kg and Pemetrexed/cisplatin every 21 days
Arm group label:
Bevacizumab and Pemetrexed/cisplatin
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University of Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
li-kun Chen, doctor
Phone:
13798019964
Email:
chenlk@sysucc.org.cn
Start date:
June 2013
Completion date:
June 2020
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01951482
