- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01588704
Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
January 21, 2015 updated by: Si-Yu Wang
A Phase II Study of Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
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.
Study Overview
Detailed Description
This trial investigates the role of neoadjuvant pemetrexed, carboplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Sun Yat-sen University Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neoadjuvant Bevacizumab
Four cycles of neoadjuvant chemotherapy with pemetrexed, carboplatin and bevacizumab.
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Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab followed by surgical resection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Resectability rate
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 2 years
|
2 years
|
Number of participants with perioperative complications
Time Frame: 4 months
|
4 months
|
Disease-free survival
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Si-Yu Wang, Doctor, Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
April 25, 2012
First Submitted That Met QC Criteria
April 30, 2012
First Posted (Estimate)
May 1, 2012
Study Record Updates
Last Update Posted (Estimate)
January 22, 2015
Last Update Submitted That Met QC Criteria
January 21, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Adenocarcinoma
- Adenocarcinoma of Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Folic Acid Antagonists
- Bevacizumab
- Pemetrexed
Other Study ID Numbers
- GASTO1001
- wsy002 (Other Identifier: Guangdong Province Association Study of Thoracic Oncology)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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