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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01514877
First received: January 17, 2012
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Metastatic Cancer
Drug: Icotinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Icotinib Combined With Whole Brain Radiotherapy in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Zhejiang Cancer Hospital:

Primary Outcome Measures:
  • partial response rate of intracranial lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Partial response rate of intracranial lesions will be measured.


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Progression-free survival will be evaluated

  • overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Overall survival will be evaluated

  • partial response rate of extracranial lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Partial response rate of extracranial lesions will be evaluated

  • Health-related quality of life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Health-related quality of life will be measured

  • safety and tolerability [ Time Frame: 4 year ] [ Designated as safety issue: Yes ]
    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

  • the relationship between Progression-Free Survival and EGFR mutation status [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    The relationship between Progression-Free Survival and EGFR mutation status will be evaluated.


Enrollment: 20
Study Start Date: January 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Icotinib plus Whole Brain Radiotherapy
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514877

Locations
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
Principal Investigator: Yun Fan, MD Zhejiang Cancer Hospital
  More Information

No publications provided

Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01514877     History of Changes
Other Study ID Numbers: ZhejiangCH-LCBM-1201
Study First Received: January 17, 2012
Last Updated: July 22, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Zhejiang Cancer Hospital:
tumors metastatic to brain
non-small cell lung cancer
Icotinib

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014