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Pemetrexed/Cisplatin With or Without Bevacizumab in Brain Metastases From Non Squamous Non-small Cell Lung Cancer
Conditions
Non Squamous Non-small Cell Lung Cancer - Brain Metastases - Bevacizumab
Conditions: official terms
Brain Neoplasms - Carcinoma, Non-Small-Cell Lung - Lung Neoplasms - Neoplasm Metastasis
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Pemetrexed/cisplatin
Type: Drug
Name: Bevacizumab and Pemetrexed/cisplatin
Type: Drug
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
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
Location
Sun Yat-sen University of Cancer Center
Guangzhou, Guangdong, China
Status: Recruiting
Contact: li-kun Chen, doctor - 13798019964 - chenlk@sysucc.org.cn
Start Date
June 2013
Completion Date
June 2017
Sponsors
Sun Yat-sen University
Source
Sun Yat-sen University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page