Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma

Lung Cancer Clinical Trial

Official title:

A Phase II Study of Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588704
• Other study ID #: GASTO1001
• Secondary ID: wsy002
• Status: Completed
• Phase: Phase 2
• First received: April 25, 2012
• Last updated: January 21, 2015
• Start date: April 2012
• Est. completion date: April 2014

Study information

• Verified date: January 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

This trial investigates the role of neoadjuvant pemetrexed, carboplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Neoadjuvant Bevacizumab
Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab followed by surgical resection

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Si-Yu Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resectability rate		3 months	No
Secondary	Number of participants with perioperative complications		4 months	Yes
Secondary	Disease-free survival		2 years	No
Secondary	Overall survival		2 years	No