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

NCT01688713 | Unknown Phase 2 DMC

• 1 other identifier: ZhejiangCH-LCBM-1202
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases; Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (intracranial lesions)

  2 years

Secondary Outcomes (5)

• Partial response rate of intracranial lesions

  2 years

• Partial response rate of extracranial lesion

  2 years

• Overall survival

  3 years

• Health-related quality of life quality

  2 years

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

  2 years

Study Arms (1)

Icotinib,Brain metastases

EXPERIMENTAL

Drug: Icotinib

Interventions

Icotinib DRUG

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

Icotinib,Brain metastases

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

icotinib

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Weimin Mao, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun Fan, MD

CONTACT

0086-571-88122192; fanyun@csco.org.cn

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: August 27, 2012
• First Posted: September 20, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 20, 2012

Record last verified: 2012-09

Locations

CN (1)