Ignite Creation Date:
2024-05-06 @ 2:49 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02139579
Status:
UNKNOWN
Last Update Posted:
2014-05-15
First Post:
2014-05-11
Brief Title:
Efficacy and Safety Study of Bevacizumab Plus Chemotherapy in EGFR-TKI Resistant Non-Squamous Non-Small Cell Lung Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
An Open-labeled Single Arm Multicenter Phase II Study to Evaluate Efficacy and Safety of Bevacizumab Plus Chemotherapy for Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer With EGFR-TKI Resistance
Status:
UNKNOWN
Status Verified Date:
2014-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Epidermal growth factor receptor EGFR tyrosine kinase is one of most popular target molecules in the field of anticancer drug research EGFR is highly expressed in many types of tumor cells which could activate EGFR cytosolic kinase activity by binding to its ligand EGF and regulates gene expression cell proliferation differentiation apoptosis through different signal transduction pathways Epidermal growth factor receptor tyrosine kinase inhibitor EGFR-TKI competitive to specifically combined with the EGFR kinase domain thus inhibits its kinase activity thereby blocking cancer cell proliferation or metastasis At present EGFR-TKI has been widely used in clinical activity especially in patients with EGFR mutations which had been proved to achieved a certain effect But with the passage of time a drug resistance is inevitable
At present studies have found that the cessation of treatment immediately after EGFR-TKI resistance may lead to rapid progress of cancer Chemotherapy as one of the most widely accepted modality in cancer treatment might also be one of the salvage therapies of target treatment Therefore in patients with better physical status PS scores chemotherapy is commonly applicable
In January 2010 a study published in the journal of Clinical Lung Cancer reported the application of chemotherapy as salvage treatment for advanced non-small cell lung cancer NSCLC patients with resistant to first-line EGFR-TKI treatment Of the 114 patients enrolled 67 received sequential chemotherapy the other 47 patients received best supportive care The results showed that sequential chemotherapy can improve the survival time of the patients compared with chemotherapy and supportive care groups 112 months vs 38 months P 001 Furthermore in those who received sequential chemotherapy a regimen containing paclitaxel got higher efficiency and disease control rate than those without 487 vs 214 795 vs 535 P 005 as well as longer progression-free survival PFS 51 months vs 18 months P 001 and overall survival OS 127 months vs 7 months P 001
Another study in Taiwan which enrolled 195 patients treated with at least 1 cycles sequential chemotherapy after first-line gefitinib shown similar results Generally gefitinib as a first-line treatment had PFS for 5 months and the second-line treatment efficiency was 144 Regimens of platinum or paclitaxel had a better treatment efficiency 506 A poor therapeutic effect was reported for gefitinib as second-line therapy 56 In total the median OS of second-line treatment was 122 months In addition platinum containing regimens survival better 217 months vs 89 months P 001 patients with mutant EGFR benefit more in a platinum-based chemotherapy 245 months vs 85 months P 005
Bevacizumab trade name Avastin is a kind of recombinant humanized monoclonal immunoglobulin gamma-1 IgG1 antibody which can selectively inhibit the combination process of vascular endothelial growth factor VEGF and its receptor Flt-1 and kinase domain receptor KDR in endothelial cells A reduction of tumor angiogenesis blood supply oxygen and other nutrients supply could be obtained after the VEGF loss of its biological activity thus inhibit tumor growth The drug was approved for the first-line treatment of advanced colorectal cancer in 2004 by America food and Drug Administration FDAthus became the first for clinical use of drugs that targeting VEGF As the first globally approved anti-angiogenic monoclonal antibody drugs bevacizumab has approved for advanced colorectal cancer lung cancer breast cancer renal cell carcinoma and malignant glioma patients which was used in more than 500000 cases In the field of advanced NSCLC treatment clinical results confirm bevacizumab combined with chemotherapy can prolong OS and PFS of patients with NSCLC and well tolerated
The thirty-fifth annual meeting of the European Society of Medical Oncology ESMO conference released a meta analysis results of bevacizumab combined with platinum chemotherapy for first-line treatment of advanced non squamous NSCLC It is confirmed that treatment with bevacizumab based chemotherapy for advanced non squamous NSCLC patients could achieve significant survival benefit prolong remission time and expected safety
Therefore the investigators design this phase II to testify the efficacy and safety of bevacizumab chemotherapy for EGFR-TKI resistant non squamous NSCLC
At present studies have found that the cessation of treatment immediately after EGFR-TKI resistance may lead to rapid progress of cancer Chemotherapy as one of the most widely accepted modality in cancer treatment might also be one of the salvage therapies of target treatment Therefore in patients with better physical status PS scores chemotherapy is commonly applicable
In January 2010 a study published in the journal of Clinical Lung Cancer reported the application of chemotherapy as salvage treatment for advanced non-small cell lung cancer NSCLC patients with resistant to first-line EGFR-TKI treatment Of the 114 patients enrolled 67 received sequential chemotherapy the other 47 patients received best supportive care The results showed that sequential chemotherapy can improve the survival time of the patients compared with chemotherapy and supportive care groups 112 months vs 38 months P 001 Furthermore in those who received sequential chemotherapy a regimen containing paclitaxel got higher efficiency and disease control rate than those without 487 vs 214 795 vs 535 P 005 as well as longer progression-free survival PFS 51 months vs 18 months P 001 and overall survival OS 127 months vs 7 months P 001
Another study in Taiwan which enrolled 195 patients treated with at least 1 cycles sequential chemotherapy after first-line gefitinib shown similar results Generally gefitinib as a first-line treatment had PFS for 5 months and the second-line treatment efficiency was 144 Regimens of platinum or paclitaxel had a better treatment efficiency 506 A poor therapeutic effect was reported for gefitinib as second-line therapy 56 In total the median OS of second-line treatment was 122 months In addition platinum containing regimens survival better 217 months vs 89 months P 001 patients with mutant EGFR benefit more in a platinum-based chemotherapy 245 months vs 85 months P 005
Bevacizumab trade name Avastin is a kind of recombinant humanized monoclonal immunoglobulin gamma-1 IgG1 antibody which can selectively inhibit the combination process of vascular endothelial growth factor VEGF and its receptor Flt-1 and kinase domain receptor KDR in endothelial cells A reduction of tumor angiogenesis blood supply oxygen and other nutrients supply could be obtained after the VEGF loss of its biological activity thus inhibit tumor growth The drug was approved for the first-line treatment of advanced colorectal cancer in 2004 by America food and Drug Administration FDAthus became the first for clinical use of drugs that targeting VEGF As the first globally approved anti-angiogenic monoclonal antibody drugs bevacizumab has approved for advanced colorectal cancer lung cancer breast cancer renal cell carcinoma and malignant glioma patients which was used in more than 500000 cases In the field of advanced NSCLC treatment clinical results confirm bevacizumab combined with chemotherapy can prolong OS and PFS of patients with NSCLC and well tolerated
The thirty-fifth annual meeting of the European Society of Medical Oncology ESMO conference released a meta analysis results of bevacizumab combined with platinum chemotherapy for first-line treatment of advanced non squamous NSCLC It is confirmed that treatment with bevacizumab based chemotherapy for advanced non squamous NSCLC patients could achieve significant survival benefit prolong remission time and expected safety
Therefore the investigators design this phase II to testify the efficacy and safety of bevacizumab chemotherapy for EGFR-TKI resistant non squamous NSCLC
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None