Clinical Trials /

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

NCT01951482

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: NSCLC brain metastasis 02
  • NCT ID: NCT01951482

Conditions

  • Non Squamous Non-small Cell Lung Cancer
  • Brain Metastases
  • Bevacizumab

Interventions

DrugSynonymsArms
Pemetrexed/cisplatinPemetrexed/cisplatin
Bevacizumab and Pemetrexed/cisplatinBevacizumab and Pemetrexed/cisplatin

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Bevacizumab and Pemetrexed/cisplatinExperimentalBevacizumab 7.5mg/kg d1+Pemetrexed/cisplatin q21d
  • Bevacizumab and Pemetrexed/cisplatin
Pemetrexed/cisplatinActive ComparatorPemetrexed/cisplatin q21d
  • Pemetrexed/cisplatin

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
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Compare iPFS(intracranial progression free survival) in two arms
Time Frame:3 Years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Response rate(CR&PR)
Time Frame:3 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sun Yat-sen University

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