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

NCT01588704 | Completed Phase 2

• 2 other identifiers: GASTO1001wsy002
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

lung cancer; lung adenocarcinoma; bevacizumab; adjuvant chemotherapy; surgical resection rate; safety; feasibility

Outcome Measures

Primary Outcomes (1)

• Resectability rate

  3 months

Secondary Outcomes (3)

• Number of participants with perioperative complications

  4 months

• Disease-free survival

  2 years

• Overall survival

  2 years

Study Arms (1)

Neoadjuvant Bevacizumab

EXPERIMENTAL

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

Drug: Neoadjuvant Bevacizumab

Interventions

Neoadjuvant Bevacizumab DRUG

Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab followed by surgical resection

Also known as: Pemetrexed (Alimta), Bevacizumab (Avastin)

Neoadjuvant Bevacizumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Si-Yu Wang: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma of Lung

Interventions

Pemetrexed; Bevacizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Si-Yu Wang, Doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: May 1, 2012
• Study Start: April 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 22, 2015

Record last verified: 2015-01

Locations

CN (1)