- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01688713
Phase II Trial of Double Dose of Icotinib in Treating Brain Metastases From Non-small Cell Lung Cancer
September 19, 2012 updated by: Zhejiang Cancer Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yun Fan, MD
- Phone Number: 0086-571-88122192
- Email: fanyun@csco.org.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310022
- Recruiting
- Zhejiang Cancer Hospital
-
Contact:
- Yun Fan, MD
- Phone Number: 0086-571-88122192
- Email: fanyun@csco.org.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Icotinib,Brain metastases
|
The patients will receive Icotinib in doses of 250mg thrice per day until disease progression or undue toxicity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival (intracranial lesions)
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 3 years
|
3 years
|
Partial response rate of intracranial lesions
Time Frame: 2 years
|
2 years
|
Partial response rate of extracranial lesion
Time Frame: 2 years
|
2 years
|
Health-related quality of life quality
Time Frame: 2 years
|
2 years
|
number of adverse events such as skin rash,diarrhea ,abnormal liver function and so on
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Weimin Mao, MD, Zhejiang Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Anticipated)
February 1, 2015
Study Completion (Anticipated)
September 1, 2015
Study Registration Dates
First Submitted
August 27, 2012
First Submitted That Met QC Criteria
September 19, 2012
First Posted (Estimate)
September 20, 2012
Study Record Updates
Last Update Posted (Estimate)
September 20, 2012
Last Update Submitted That Met QC Criteria
September 19, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Neoplastic Processes
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Neoplasm Metastasis
- Brain Neoplasms
Other Study ID Numbers
- ZhejiangCH-LCBM-1202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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