Icotinib Combined With WBRT For NSCLC Patients With Brain Metastases and EGFR Mutation
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Purpose
The purpose of this study is to evaluate the safety and tolerability of Icotinib at different dose levels in combination with whole brain radiotherapy for NSCLC patients with brain metastases and EGFR mutation.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer Brain Metastases |
Drug: icotinib Radiation: Whole brain radiotherapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single Center, Open Label, Dose-Finding Study to Determine the Safety of Icotinib in Combination With Whole Brain Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation. |
- Safety and tolerability [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]All cause adverse events (AEs) and serious adverse events (SAEs)
- Neurological progression-free survival [ Time Frame: 3-6 month ] [ Designated as safety issue: No ]All cause neurological progress or mortality
- Progression-free survival [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]All cause progress or mortality
- Overall survival [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]All cause mortality
- Response rate [ Time Frame: 3-6 month ] [ Designated as safety issue: No ]
- Quality of life measured by FACT-L/LCS 4.0 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Neurocognitive effects [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]Evaluated according to Mini-Mental Status Examination
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Icotinib+WBRT
Standard whole brain radiotherapy plus icotinib, which is designed to administered at 5 dose according to "3+3" until disease progression or intolerable toxicity.
|
Drug: icotinib
Level 1: Standard whole brain radiation therapy plus icotinib 125 mg Tid (375 mg per day) from day1 until disease progression or intolerable toxicity. Level 2: Standard whole brain radiation therapy plus icotinib 250 mg Tid (750 mg per day) from day1 until disease progression or intolerable toxicity. Level 3: Standard whole brain radiation therapy plus icotinib 375 mg Tid (1125 mg per day) from day1 until disease progression or intolerable toxicity. Level 4:Standard whole brain radiation therapy plus icotinib 500 mg Tid (1500 mg per day) from day1 until disease progression or intolerable toxicity. Level 5: Standard whole brain radiation therapy plus icotinib 625 mg Tid (1875 mg per day) from day1 until disease progression or intolerable toxicity. Other Name: BPI-2009, Conmana
Radiation: Whole brain radiotherapy
Whole Brain Radiation Therapy (WBRT) for total dose of 37.5Gy in 15 daily fractions beginning after Day 7.
Other Names:
|
Detailed Description:
The long-term control of brain metastases becomes a clinical challenge. Whole brain radiotherapy, the standard treatment for patients with multiple brain metastases, can only bring a modest survival improvement around 3-6 months. EGFR-TKIs like icotinib with its proven activity in non-small cell lung cancer may provide clinical benefits in such patients.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological or cytological confirmation of non-small cell lung cancer (NSCLC).
- Diagnosis of brain metastases on a Gadolinium-enhanced MRI. More than 3 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm.
- Positive EGFR mutation.
Exclusion Criteria:
- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
- CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
Contacts and Locations| Contact: You Lu, M.D. | 0086-28-85423571 | radyoulu@163.com |
| China, Sichuan | |
| West China Hospital | Recruiting |
| Chengdu, Sichuan, China, 610041 | |
| Contact: You Lu | |
| Principal Investigator: You Lu | |
| Principal Investigator: | You Lu | West China Hospital |
More Information
No publications provided
| Responsible Party: | Zhejiang Beta Pharma Inc. |
| ClinicalTrials.gov Identifier: | NCT01516983 History of Changes |
| Other Study ID Numbers: | BD-IC-IV04 |
| Study First Received: | January 10, 2012 |
| Last Updated: | April 3, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Zhejiang Beta Pharma Inc.:
|
Safety EGFR-TKI NSCLC Icotinib WBRT |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Brain Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Neoplastic Processes Pathologic Processes Central Nervous System Neoplasms Nervous System Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013