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.
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
Drug | Synonyms | Arms |
---|
Pemetrexed/cisplatin | | Pemetrexed/cisplatin |
Bevacizumab and Pemetrexed/cisplatin | | Bevacizumab 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
Name | Type | Description | Interventions |
---|
Bevacizumab and Pemetrexed/cisplatin | Experimental | Bevacizumab 7.5mg/kg d1+Pemetrexed/cisplatin q21d | - Bevacizumab and Pemetrexed/cisplatin
|
Pemetrexed/cisplatin | Active Comparator | Pemetrexed/cisplatin q21d | |
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: | Unknown status |
Lead Sponsor: | Sun Yat-sen University |
Last Updated
October 26, 2017