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Gefitinib With or Without Pemetrexed/Cisplatin in Brain Metastases From Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01951469
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:
Collaborator:
Wu Jieping Medical Foundation
Information provided by (Responsible Party):
Li-kun Chen, Sun Yat-sen University

Brief Summary:
This is a multi-center phase II randomized controlled study to assess the efficacy of Gefitinib alone and Gefitinib combinating with Pemetrexed/cisplatin on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR mutation type by intracranial PFS(iPFS),also PFS ,DCR and OS.The side effect is evaluated as well.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Brain Metastases EGFR Mutation Drug: Gefitinib and Pemetrexed/cisplatin Drug: Gefitinib mono-therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase II Study of Gefitinib Mono-therapy or Gefitinib Combined With Pemetrexed/Cisplatin in Patients With Brain Metastases From Non-small Cell Lung Cancer Harboring EGFR Mutation
Study Start Date : June 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Gefitinib and Pemetrexed/cisplatin
Gefitinib 250mg is Taken Orally on day 4-28,combined Pemetrexed/cisplatin chemotherapy on day 1-3, every 28 days
Drug: Gefitinib and Pemetrexed/cisplatin
Gefitinib 250mg is Taken Orally on day 4-28,combined Pemetrexed/cisplatin chemotherapy on day 1-3, every 28 days

Active Comparator: Gefitinib mono-therapy
Gefitinib 250mg is Taken Orally everyday
Drug: Gefitinib mono-therapy
Gefitinib 250mg is Taken Orally everyday




Primary Outcome Measures :
  1. comparing the difference of iPFS(intracranial progression free survival) in two arms [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. comparing the difference of Response rate(CR&PR) and in two arms [ Time Frame: 3 years ]

Other Outcome Measures:
  1. PFS(Progression Free Survival) [ Time Frame: 3 years ]
  2. OS(Overall Survival) [ Time Frame: 3 years ]


Information from the National Library of Medicine

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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 NSCLC with EGFR activating mutation and brain metastases by pathologic histology or cytology
  2. Patients who had never received therapy (including chemotherapy,WBRT,EGFR-TKI and EGFR monoclonal antibody) 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 until 8 weeks after the last administration of icotinib.
  6. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

Exclusion Criteria:

  1. Patient was received irradiation of brain. Patient with meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid.
  2. Patient is received the treatment of Phenytoin, carbamazepine, rifampicin, phenobarbital, or St. John's Wort.
  3. Patient was received EGFR Tyrosine Kinase Inhibitor or EGFR monoclonal antibody.
  4. Interstitial pneumonia.Pericardial effusion, pleural effusion is uncontrolled .
  5. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
  6. Any significant ophthalmologic abnormality ,especially severe dry eye syndrome ,keratoconjunctivitis sicca,Sjogren syndrome,severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions.
  7. Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
  8. The symptoms of increased intracranial pressure are uncontrolled after dehydration and cortisone treatment

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): NCT01951469


Contacts
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Contact: li-kun Chen, MD 13798019964 chenlk@sysucc.org.cn

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   
Principal Investigator: li-kun Chen, doctor         
Sponsors and Collaborators
Sun Yat-sen University
Wu Jieping Medical Foundation

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Responsible Party: Li-kun Chen, medical doctor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01951469     History of Changes
Other Study ID Numbers: NSCLC brain metastasis 01
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
Cisplatin
Pemetrexed
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors