Efficacy of Erlotinib for Brain Metastasis of Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00663689
Recruitment Status : Unknown
Verified April 2008 by Guangdong Provincial People's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 22, 2008
Last Update Posted : April 22, 2008
Information provided by:
Guangdong Provincial People's Hospital

Brief Summary:
This is a non-randomized open-label uncontrolled phase II trial evaluating efficacy and toxicity of erlotinib in patients with asymptomatic brain metastasis advanced NSCLC who was benefitted by first line chemotherapy. Patients with stage IV NSCLC who have one or more asymptomatic brain metastasis who was benefitted by first line chemotherapy will receive oral erlotinib 150mg once daily until disease progression or unacceptable toxicity. These patients' direct DNA sequencing of tumor tissue EGFR exons 18-21 will be analyzed The response was evaluated by RECIST criteria after the patient received erlotinib 6 weeks.If the patients present with progress disease of brain metastasis after the therapy of erlotinib, the patients will receive irradiation of brain metastasis.If the response is stable disease,partial response or complete response,he will be examined by brain MRI every 12 weeks.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Brain Metastases Drug: erlotinib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Erlotinib in Benefitted Patients With Asymptomatic Brain Metastases Advanced Non-Small Cell Lung Cancer By Chemotherapy.
Study Start Date : March 2008
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
non-randomized open-label uncontrolled phase II trial erlotinib 150mg qd until disease progression or unacceptable toxicity
Drug: erlotinib
erlotinib 150mg qd until disease progression or unacceptable toxicity.
Other Name: TARVECA

Primary Outcome Measures :
  1. Time of asymptomatic brain metastasis turn into symptomatic brain metastasis [ Time Frame: 3/2008~3/2011 ]

Secondary Outcome Measures :
  1. To determine objective response (CR+PR), time to progression, 6-month survival and 1-year survival,safety. [ Time Frame: 3/2008~3/2011 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Histological or cytological documented stage IV NSCLC. Sputum cytology alone is excluded
  2. Extracerebral lesions show stable disease after first line chemotherapy. Patient has recovered from CTCAE grade 3/4 toxicity. Patients who had never received EGFR-TKI or EGFR monoclonal antibody.
  3. Patients must be at least 18 years.
  4. ECOG Performance Status 0, 1 or 2.
  5. Life expectancy of at least 12 weeks.
  6. Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI.
  7. Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L.
  8. Total bilirubin £ 1.5 x upper limit of normal (ULN)
  9. ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.
  10. Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula).
  11. PT-INR/PTT < 1.2 x ULN.
  12. Written informed consent.
  13. Able to comply with study and follow-up procedures.

Exclusion criteria:

  1. Mixed small cell and non-small cell lung cancer histology.
  2. Any unresolved toxicity>CTCAE grade 2 from previous anti-cancer therapy.
  3. Patients with exposure to biotherapy, immunotherapy within 4 weeks of study entry.
  4. Other concurrent anticancer therapy.
  5. Patients with exposure to investigational drug therapy outside of this trial.
  6. Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
  7. Any unstable systemic disease (including active infection, hepatic, renal, metabolic disease or seizure disorder requiring medication).
  8. Significant cardiovascular event: congestive heart failure >NYHA class 2; unstable angina, active CAD (myocardial infarction more than 1 year prior to study entry is allowed); serious cardiac arrhythmia requiring anti-arrhythmic therapy ( beta blockers or digoxin are permitted) or uncontrolled hypertension.
  9. Brain metastases or spinal cord compression, if treated before the start of study treatment, and have any symptoms. Symptoms include signs of increased intracranial pressure ,headache,nausea and vomiting,cognitive or affective disturbances,seizures,and focal neurologic symptoms.
  10. History of another malignancy within the last 5 years except cured carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and superficial bladder tumors [Ta, Tis & T1].
  11. Pregnant or breast-feeding women.
  12. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
  13. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00663689

Sponsors and Collaborators
Guangdong Provincial People's Hospital
Principal Investigator: Wu Yilong, MD Cancer center of Guangdong PPH

Responsible Party: Yilong,Wu, Guangdong Provincial People's Hospital Identifier: NCT00663689     History of Changes
Other Study ID Numbers: cslc0803
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: April 2008

Keywords provided by Guangdong Provincial People's Hospital:

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action