A Phase II Study of Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
Overview
- Phase
- Phase 2
- Intervention
- Neoadjuvant Bevacizumab
- Conditions
- Lung Cancer
- Sponsor
- Si-Yu Wang
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Resectability rate
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Si-Yu Wang
Professor
Sun Yat-sen University
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
Arms & Interventions
Neoadjuvant Bevacizumab
Four cycles of neoadjuvant chemotherapy with pemetrexed, carboplatin and bevacizumab.
Intervention: Neoadjuvant Bevacizumab
Outcomes
Primary Outcomes
Resectability rate
Time Frame: 3 months
Secondary Outcomes
- Number of participants with perioperative complications(4 months)
- Overall survival(2 years)
- Disease-free survival(2 years)