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

Lung Cancer Clinical Trial

Official title:

Phase II Study of Icotinib Combined With Whole Brain Radiotherapy in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514877
• Other study ID #: ZhejiangCH-LCBM-1201
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2012
• Last updated: July 22, 2014
• Start date: January 2012
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• Icotinib
Patients will receive whole brain radiotherapy therapy 30Gy over 10 fractions and icotinib will be administered at the beginning of whole brain radiotherapy in doses of 125 mg thrice per day until disease progression or undue toxicity.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	partial response rate of intracranial lesions	Partial response rate of intracranial lesions will be measured.	2 years	No
Secondary	Progression-free survival	Progression-free survival will be evaluated	4 years	No
Secondary	overall survival	Overall survival will be evaluated	4 years	No
Secondary	partial response rate of extracranial lesions	Partial response rate of extracranial lesions will be evaluated	2 years	No
Secondary	Health-related quality of life	Health-related quality of life will be measured	2 years	Yes
Secondary	safety and tolerability	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	4 year	Yes
Secondary	the relationship between Progression-Free Survival and EGFR mutation status	The relationship between Progression-Free Survival and EGFR mutation status will be evaluated.	4 years	No