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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Guangdong Provincial People's Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier:
NCT00614809
First received: January 31, 2008
Last updated: February 13, 2008
Last verified: December 2007
  Purpose

This is a non-randomized open-label uncontrolled phase II trial evaluating efficacy and toxicity of gefitinib in patients with asymptomatic 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 gefitinib 250mg 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 gefitinib 6 weeks.If the patients present with progress disease of brain metastasis after the therapy of gefitinib, 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 Metastasis
Drug: gefitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Gefitinib in Benefited Patients With Asymptomatic Brain Metastasis Advanced Non-Small Cell Lung Cancer by Chemotherapy

Resource links provided by NLM:


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: 12/2007~12/2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine objective response (CR+PR), time to progression, 6-month survival and 1-year survival,safety. [ Time Frame: 12/2007~12/2010 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: December 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
non-randomized open-label uncontrolled phase II trial
Drug: gefitinib
gefitinib 250mg qd until disease progression or unacceptable toxicity.
Other Name: IRESSA

Detailed Description:

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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614809

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

No publications provided

Responsible Party: Yilong,Wu, Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT00614809     History of Changes
Other Study ID Numbers: CSLC-0703
Study First Received: January 31, 2008
Last Updated: February 13, 2008
Health Authority: China: Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by Guangdong Provincial People's Hospital:
gefitinib
brain metastasis

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

ClinicalTrials.gov processed this record on September 22, 2014