Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Lung Cancer; Metastatic Cancer
• Interventions: Drug: Icotinib

• Registration Number: NCT01514877
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

The aim of this study is to explore the efficacy and toxicity of icotinib combined with WBRT in treating patients with multiple brain metastases from NSCLC.

Detailed Description

Brain metastases occur in 25-40% of patients with non-small cell lung cancer (NSCLC). It is one of the primary reasons resulting in treatment failure and the death. Whole-brain radiation therapy (WBRT) is the standard approach to the treatment of multiple brain metastases from NSCLC. Regardless of the treatment of brain metastases by WBRT combined with systemic chemotherapy,outcomes of NSCLC with brain metastases are still very poor. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) can pass through the blood-brain barrier and show promising antitumor activity against brain metastases from NSCLC. Icotinib shows nearly the same effect as gefitinib in advanced NSCLC patients failed with chemotherapy.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-23
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-22
• Last Update Posted: 2014-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Cytologic or histological diagnosis of non-small cell lung cancer
• Patients with disease progression after systemic chemotherapy with two-drug combination regimens that includes a platinum agent or patients with EGFR mutation status who have not been treated
• Patients are diagnosed with multiple brain metastases for the first time in 4 weeks
• Diagnosis of brain metastases is made based on Magnetic resonance imaging (MRI).
• Doctors consider the patient will benefit from WBRT
• No prior brain radiotherapy
• ECOG performance status 0-2
• age:18-75 years
• Neutrophil count ≥1.5×10 to the 9th power/L and platelets≥100×10 to the 9th power/L. hemoglobin ≥90 g/L
• Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement)
• Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN)
• Patients with measurable brain metastases according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• Patients must sign an informed consent indicating that they are aware of the investigational nature of the study

Exclusion Criteria

• Prior brain radiation therapy
• Solitary brain metastasis according to Magnetic resonance imaging (MRI)
• Mort than 3 extracranial organs have metastatic lesions
• Prior invasive malignancy (skin basal cell cancer, carcinoma in situ of cervix are permissible).
• pregnant or breast feeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Icotinib plus Whole Brain Radiotherapy	Icotinib	Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), such as gefitinib and erlotinib, have shown efficacy in advanced non-small cell lung cancer (NSCLC) patients with brain metastases (BM). Icotinib is a new first generation EGFR-TKI. We conducted a phase II study to evaluate the efficacy and safety of icotinib in combination with whole brain radiotherapy （WBRT） in Chinese NSCLC patients with BM and investigated the cerebrospinal fluid (CSF)/ plasma concentrations of icotinib.

Primary Outcome Measures

Name	Time	Method
partial response rate of intracranial lesions	2 years	Partial response rate of intracranial lesions will be measured.

Secondary Outcome Measures

Name	Time	Method
the relationship between Progression-Free Survival and EGFR mutation status	4 years	The relationship between Progression-Free Survival and EGFR mutation status will be evaluated.
overall survival	4 years	Overall survival will be evaluated
Progression-free survival	4 years	Progression-free survival will be evaluated
partial response rate of extracranial lesions	2 years	Partial response rate of extracranial lesions will be evaluated
Health-related quality of life	2 years	Health-related quality of life will be measured
safety and tolerability	4 year	Safety and tolerability of Icotinib and whole brain radiotherapy will be monitored by evaluation of frequency,severity,and duration of treatment-emergent adverse events in all subjects

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China