Phase II Trial of Double Dose of Icotinib in Treating Brain Metastases From Non-small Cell Lung Cancer
Conditions
Brain Metastases - Non-small Cell Lung Cancer
Conditions: official terms
Brain Neoplasms - Carcinoma, Non-Small-Cell Lung - Neoplasm Metastasis
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Icotinib
Type: Drug
Overall Status
Recruiting
Summary
Brain metastases, a common complication,occur in 25-40% of patients with non-small cell lung cancer (NSCLC). Whole-brain radiation therapy(WBRT) and Stereotactic Radiosurgery (SRS) are important approaches to the treatment of brain metastases from NSCLC. Known to us, 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, especially for EGFR mutation patients. However, due to the lower concentration of tyrosine kinase inhibitors (TKIs) in the cerebrospinal fluid and its inevitable emergence of drug resistance, brain metastases will be refractory or resistant to standard-dose EGFR inhibitors. Icotinib is one agent of EGFR-TKIs. The previous studies have shown that the Icotinib conventional dose (125mg, TID) is far from reached its maximum tolerable dose. It is a challenge whether the further dose escalation of Icotinib will enhance its concentration in cerebrospinal fluid and thereby improve its therapeutic effect. Here the investigators examine the therapeutic effect and side-effect of double dose of Icitinib in treating patients with brain metastases from NSCLC who have suffered from the failure of conventional dose treatment.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histological or cytologic diagnosis of NSCLC

- Patients with disease progression after local treatment(WBRT and/or SRS) combined with Icotinib treatment.

- Patients with EGFR mutation or the lesions that remains stable for more than 3 months after local treatment(WBRT and/or SRS) combined with Icotinib treatment.

- ECOG performance status 0-2

- Doctors consider the patients will not benefit from local treatment(WBRT and/or SRS)

- Expected survival of greater than 3 months

- Age: 18-75 years

- The patients with key organs maintenance of basic function: Hemoglobin ≥ 9g/dL, White Blood Cell ≥ 3×109/L, Neutrophil count ≥ 1.5×109/L, platelets ≥ 80×109/L, total bilirubin < 1.5 times of the upper normal values, Alanine transaminase (ALT) and aspartate transaminase (AST) < 2.5 of the upper normal values, the serum creatinine < 1.5 times of the upper normal values

- Signed informed consent document on file.

Exclusion Criteria:

- Brain metastasis without local treatment before

- Patients without the treatment of Icotinib before or the therapeutic time less than 3 months

- More than 3 extracranial organs have metastatic lesions

- The patient with other type malignant tumors before

- The patient with fertility capacity, but without contraceptive application
Location
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Status: Recruiting
Contact: Yun Fan, MD - 0086-571-88122192 - fanyun@csco.org.cn
Start Date
August 2012
Completion Date
September 2015
Sponsors
Zhejiang Cancer Hospital
Source
Zhejiang Cancer Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page