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Phase II Trial of Double Dose of Icotinib in Treating Brain Metastases From Non-small Cell Lung Cancer

Primary Purpose

Brain Metastases, Non-small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Icotinib

About this trial

This is an interventional treatment trial for Brain Metastases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Icotinib,Brain metastases

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival (intracranial lesions)

Secondary Outcome Measures

Partial response rate of intracranial lesions

Partial response rate of extracranial lesion

Overall survival

Health-related quality of life quality

number of adverse events such as skin rash,diarrhea ,abnormal liver function and so on

Full Information

NCT ID

NCT01688713

First Posted

August 27, 2012

Last Updated

September 19, 2012

Sponsor

Zhejiang Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01688713

Brief Title

Phase II Trial of Double Dose of Icotinib in Treating Brain Metastases From Non-small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Unknown status

Study Start Date

August 2012 (undefined)

Primary Completion Date

February 2015 (Anticipated)

Study Completion Date

September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhejiang Cancer Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Metastases, Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Icotinib,Brain metastases

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Icotinib

Intervention Description

The patients will receive Icotinib in doses of 250mg thrice per day until disease progression or undue toxicity.

Primary Outcome Measure Information:

Title

Progression-free survival (intracranial lesions)

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Partial response rate of intracranial lesions

Time Frame

2 years

Title

Partial response rate of extracranial lesion

Time Frame

2 years

Title

Overall survival

Time Frame

3 years

Title

Health-related quality of life quality

Time Frame

2 years

Title

number of adverse events such as skin rash,diarrhea ,abnormal liver function and so on

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yun Fan, MD

Phone

0086-571-88122192

fanyun@csco.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Weimin Mao, MD

Organizational Affiliation

Zhejiang Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhejiang Cancer Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yun Fan, MD

Phone

0086-571-88122192

fanyun@csco.org.cn

12. IPD Sharing Statement

Learn more about this trial

Phase II Trial of Double Dose of Icotinib in Treating Brain Metastases From Non-small Cell Lung Cancer

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