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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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ClinicalTrials.gov Identifier: NCT01951482
Recruitment Status : Unknown
Verified October 2017 by Li-kun Chen, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : September 26, 2013
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Li-kun Chen, Sun Yat-sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non Squamous Non-small Cell Lung Cancer Brain Metastases Bevacizumab Drug: Pemetrexed/cisplatin Drug: Bevacizumab and Pemetrexed/cisplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Bevacizumab and Pemetrexed/cisplatin
Bevacizumab 7.5mg/kg d1+Pemetrexed/cisplatin q21d
 Drug: Bevacizumab and Pemetrexed/cisplatin
receive Bevacizumab 7.5mg/kg and Pemetrexed/cisplatin every 21 days
Active Comparator: Pemetrexed/cisplatin
Pemetrexed/cisplatin q21d
 Drug: Pemetrexed/cisplatin
receive Pemetrexed/cisplatin every 21 days


Outcome Measures
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Primary Outcome Measures :
  1. Compare iPFS(intracranial progression free survival) in two arms [ Time Frame: 3 Years ]

Secondary Outcome Measures :
  1. Response rate(CR&PR) [ Time Frame: 3 years ]

Other Outcome Measures:
  1. PFS: progress free survival [ Time Frame: 3 years ]
  2. OS: overall survival [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951482


Contacts
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Contact: li-kun hen, Doctor 13798019964

Locations
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China, Guangdong
Sun Yat-sen University of Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: li-kun Chen, doctor    13798019964    chenlk@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Director: li-kun Chen, Doctor Sun Yat-sen University
More Information
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Responsible Party: Li-kun Chen, medical doctor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01951482    
Other Study ID Numbers: NSCLC brain metastasis 02
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
 Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bevacizumab
Cisplatin
Pemetrexed
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors