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

Last updated: October 25, 2017
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

2

Condition

Brain Metastases

Neoplasm Metastasis

Treatment

N/A

Clinical Study ID

NCT01951482
NSCLC brain metastasis 02
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient who was confirmed stage IV non squamous NSCLC with EGFR wild type and brainmetastases 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 mmby brain MRI

  4. Adult patients (≥ 18 years and ≤75 years). ECOG Performance Status 0 or 1 Lifeexpectancy 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 ofnormal (ULN). ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULNin case of liver metastases. Creatinine clearance ³ 60ml/min (calculated according toCockcroft-gault formula).

  5. Patients should be contraceptive during the period of the trial

Exclusion

Exclusion Criteria:

  1. Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with apredominant 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 wereconfirmed by MRI or cytology test of cerebrospinal fluid.

  5. Previous radiotherapy.

  6. Serious uncontrolled coagulation disorder or thrombi-embolic complications within 6months 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 tothe first bevacizumab infusion.

  9. Non-healing wound, active peptic ulcer or bone fracture.

  10. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscesswithin 6 months of enrollment

Study Design

Total Participants: 108
Study Start date:
June 01, 2013
Estimated Completion Date:
June 30, 2020

Connect with a study center

  • Sun Yat-sen University of Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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