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

NCT ID: NCT01588704

Last Updated: 2015-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-04-30

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant Bevacizumab

Four cycles of neoadjuvant chemotherapy with pemetrexed, carboplatin and bevacizumab.

Group Type: EXPERIMENTAL

Neoadjuvant Bevacizumab

Intervention Type: DRUG

Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab followed by surgical resection

Interventions

Neoadjuvant Bevacizumab

Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab followed by surgical resection

Intervention Type: DRUG

Other Intervention Names

Pemetrexed (Alimta); Bevacizumab (Avastin)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Si-Yu Wang

OTHER

Sponsor Role: lead

Responsible Party

Si-Yu Wang

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Si-Yu Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

wsy002

Identifier Type: OTHER

Identifier Source: secondary_id

GASTO1001

Identifier Type: -

Identifier Source: org_study_id