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Efficacy of Erlotinib for Brain Metastasis of Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: April 17, 2008   Last Updated: April 21, 2008   History of Changes
Sponsored by: Guangdong Provincial People's Hospital
Information provided by: Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT00663689
  Purpose

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 Intervention Phase
Non-Small Cell Lung Cancer
Brain Metastases
Drug: erlotinib
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Erlotinib hydrochloride Erlotinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: A Phase II Study of Erlotinib in Benefitted Patients With Asymptomatic Brain Metastases Advanced Non-Small Cell Lung Cancer By Chemotherapy.

Further study details as provided by Guangdong Provincial People's Hospital:

Primary Outcome Measures:
  • Time of asymptomatic brain metastasis turn into symptomatic brain metastasis [ Time Frame: 3/2008~3/2011 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 45
Study Start Date: March 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663689

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

No publications provided

Responsible Party: Guangdong Provincial People's Hospital ( Yilong,Wu )
Study ID Numbers: cslc0803
Study First Received: April 17, 2008
Last Updated: April 21, 2008
ClinicalTrials.gov Identifier: NCT00663689     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Guangdong Provincial People's Hospital:
erlotinib

Study placed in the following topic categories:
Erlotinib
Thoracic Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Protein Kinase Inhibitors
Carcinoma
Brain Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Central Nervous System Neoplasms
Brain Diseases
Protein Kinase Inhibitors
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Respiratory Tract Diseases
Lung Neoplasms
Neoplasm Metastasis
Nervous System Neoplasms
Erlotinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Pharmacologic Actions
Carcinoma
Brain Neoplasms
Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009