Back to resultsNeoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Neoadjuvant Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring lung cancer, lung adenocarcinoma, bevacizumab, adjuvant chemotherapy, surgical resection rate, safety, feasibility
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed unresectable, locally advanced (III A (bulky N2), III B) lung adenocarcinoma
- No previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer
- Adequate organ and bone marrow function
Exclusion Criteria:
- Prior chemotherapy or radiation therapy for NSCLC
- Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF)
- Patients with known hypersensitivity to other recombinant human antibodies
- History of stroke or transient ischemic attack (TIA).
- History of myocardial infarction or unstable angina within the past 12 months.
- Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection.
- Women who are pregnant or breast-feeding
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neoadjuvant Bevacizumab
Arm Description
Four cycles of neoadjuvant chemotherapy with pemetrexed, carboplatin and bevacizumab.
Outcomes
Primary Outcome Measures
Resectability rate
Secondary Outcome Measures
Number of participants with perioperative complications
Disease-free survival
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01588704
Brief Title
Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
Official Title
A Phase II Study of Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Si-Yu Wang
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The prognosis of patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) is poor. Chemoradiotherapy is the main treatment modality for this disease. The newer drug regimens can be expected to improve survival in this subset of NSCLC patients. Modern targeted therapies have enhanced the outcomes of lung cancer treatment, especially for advanced NSCLC. Among the targeted approaches for the inhibition of angiogenesis is bevacizumab, a monoclonal antibody that represses vascular endothelial growth factor (VEGF). Bevacizumab in combination with platinum-based chemotherapy used as neoadjuvant chemotherapy may change the previous treatment modality. It allows some lung cancer patients to be downstaged to surgery rather than radiotherapy. Thus, survival of these patients may be improved.
Detailed Description
This trial investigates the role of neoadjuvant pemetrexed, carboplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
lung cancer, lung adenocarcinoma, bevacizumab, adjuvant chemotherapy, surgical resection rate, safety, feasibility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neoadjuvant Bevacizumab
Arm Type
Experimental
Arm Description
Four cycles of neoadjuvant chemotherapy with pemetrexed, carboplatin and bevacizumab.
Intervention Type
Drug
Intervention Name(s)
Neoadjuvant Bevacizumab
Other Intervention Name(s)
Pemetrexed (Alimta), Bevacizumab (Avastin)
Intervention Description
Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab followed by surgical resection
Primary Outcome Measure Information:
Title
Resectability rate
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of participants with perioperative complications
Time Frame
4 months
Title
Disease-free survival
Time Frame
2 years
Title
Overall survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed unresectable, locally advanced (III A (bulky N2), III B) lung adenocarcinoma
No previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer
Adequate organ and bone marrow function
Exclusion Criteria:
Prior chemotherapy or radiation therapy for NSCLC
Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF)
Patients with known hypersensitivity to other recombinant human antibodies
History of stroke or transient ischemic attack (TIA).
History of myocardial infarction or unstable angina within the past 12 months.
Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection.
Women who are pregnant or breast-feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Si-Yu Wang, Doctor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
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