Neoadjuvant Pemetrexed, Cisplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
This study is currently recruiting participants.
Verified April 2012 by Sun Yat-sen University
Sponsor:
Siyu Wang
Information provided by (Responsible Party):
Siyu Wang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01588704
First received: April 25, 2012
Last updated: April 30, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: Neoadjuvant Bevacizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Neoadjuvant Pemetrexed, Cisplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma |
Resource links provided by NLM:
Further study details as provided by Sun Yat-sen University:
Primary Outcome Measures:
- Resectability rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Perioperative complications [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Perioperative complications, such as major hemoptysis, wound healing complications, and infection.
| Estimated Enrollment: | 36 |
| Study Start Date: | April 2012 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Neoadjuvant Bevacizumab
Four cycles of neoadjuvant chemotherapy with pemetrexed, cisplatin and bevacizumab.
|
Drug: Neoadjuvant Bevacizumab
Neoadjuvant Pemetrexed, Cisplatin and Bevacizumab followed by surgical resection
Other Names:
|
Detailed Description:
This trial investigates the role of neoadjuvant pemetrexed, cisplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588704
Contacts
| Contact: Siyu Wang, Doctor | +86 20 87343439 |
Locations
| China, Guangdong | |
| Siyu Wang | Recruiting |
| Guangzhou, Guangdong, China, 510060 | |
| Contact: Siyu Wang, Doctor | |
Sponsors and Collaborators
Siyu Wang
Investigators
| Principal Investigator: | Siyu Wang, Doctor | Sun Yat-sen University |
More Information
No publications provided
| Responsible Party: | Siyu Wang, Professor, Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT01588704 History of Changes |
| Other Study ID Numbers: | wsy002 |
| Study First Received: | April 25, 2012 |
| Last Updated: | April 30, 2012 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Sun Yat-sen University:
|
lung cancer lung adenocarcinoma bevacizumab adjuvant chemotherapy |
surgical resection rate safety feasibility |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Lung Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Pemetrexed Bevacizumab |
Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013