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

NCT01514877 | Completed Phase 2 DMC

• 1 other identifier: ZhejiangCH-LCBM-1201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Metastatic Cancer

Keywords

tumors metastatic to brain; non-small cell lung cancer; Icotinib

Outcome Measures

Primary Outcomes (1)

• partial response rate of intracranial lesions

  Partial response rate of intracranial lesions will be measured.

  2 years

Secondary Outcomes (6)

• Progression-free survival

  4 years

• overall survival

  4 years

• partial response rate of extracranial lesions

  2 years

• Health-related quality of life

  2 years

• safety and tolerability

  4 year

Study Arms (1)

Icotinib plus Whole Brain Radiotherapy

EXPERIMENTAL

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

Interventions

Icotinib DRUG

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.

Icotinib plus Whole Brain Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (1)

• Fan Y, Huang Z, Fang L, Miao L, Gong L, Yu H, Yang H, Lei T, Mao W. A phase II study of icotinib and whole-brain radiotherapy in Chinese patients with brain metastases from non-small cell lung cancer. Cancer Chemother Pharmacol. 2015 Sep;76(3):517-23. doi: 10.1007/s00280-015-2760-5. Epub 2015 Jul 7.

  PMID: 26148750 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis; Brain Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

icotinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Yun Fan, MD

  Zhejiang Cancer Hospital

  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

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 23, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 23, 2014

Record last verified: 2014-07

Locations

CN (1)