Non-Small Cell Lung CancerPhase 2NCT00614809
Efficacy of Gefitinib for Brain Metastasis of Non-Small Cell Lung Cancer
A Phase 2 study testing gefitinib in people with Non-Small Cell Lung Cancer and Brain Metastasis, run by Guangdong Provincial People's Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Brain Metastasis
- What is being tested?
- gefitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological documented stage IV NSCLC. Sputum cytology alone is excluded
- 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.
- Patients must be at least 18 years.
- ECOG Performance Status 0, 1 or 2.
- Life expectancy of at least 12 weeks.
- Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI.
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- Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L.
- Total bilirubin £ 1.5 x upper limit of normal (ULN)
- ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.
- 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.
Who cannot join
- Mixed small cell and non-small cell lung cancer histology.
- Any unresolved toxicity>CTCAE grade 2 from previous anti-cancer therapy.
- Patients with exposure to biotherapy, immunotherapy within 4 weeks of study entry.
- Other concurrent anticancer therapy.
- Patients with exposure to investigational drug therapy outside of this trial.
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
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- Any unstable systemic disease (including active infection, hepatic, renal, metabolic disease or seizure disorder requiring medication).
- 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.
- 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.
- 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].
- Pregnant or breast-feeding women.
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
About this study
Official title: A Phase II Study of Gefitinib in Benefited Patients With Asymptomatic Brain Metastasis Advanced Non-Small Cell Lung Cancer by Chemotherapy
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.
Read the detailed description
Inclusion criteria:
- Histological or cytological documented stage IV NSCLC. Sputum cytology alone is excluded.
- 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.
- Patients must be at least 18 years.
- ECOG Performance Status 0, 1 or 2.
- Life expectancy of at least 12 weeks.
- Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI.
- Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L.
- Total bilirubin £ 1.5 x upper limit of normal (ULN)
- ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.
- Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula).
- PT-INR/PTT < 1.2 x ULN.
- Written informed consent.
- Able to comply with study and follow-up procedures.
Exclusion criteria:
- Mixed small cell and non-small cell lung cancer histology.
- Any unresolved toxicity>CTCAE grade 2 from previous anti-cancer therapy.
- Patients with exposure to biotherapy, immunotherapy within 4 weeks of study entry.
- Other concurrent anticancer therapy.
- Patients with exposure to investigational drug therapy outside of this trial.
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
- Any unstable systemic disease (including active infection, hepatic, renal, metabolic disease or seizure disorder requiring medication).
- 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.
- 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.
- 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].
- Pregnant or breast-feeding women.
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
- Conditions
- Non-Small Cell Lung Cancer, Brain Metastasis
- Being tested
- gefitinib
- Keywords
- gefitinib, brain metastasis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gefitinibDrug
Also called IRESSA
gefitinib 250mg qd until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | non-randomized open-label uncontrolled phase II trial Receives: Drug: gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of asymptomatic brain metastasis turn into symptomatic brain metastasis
Measured: 12/2007~12/2010
Secondary outcomes (1)
To determine objective response (CR+PR), time to progression, 6-month survival and 1-year survival,safety.
Measured: 12/2007~12/2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionMar 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wu yilong, MD, Principal investigator, Director of cancer center of Guangdong PPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614809
- Sponsor's protocol ID
- CSLC-0703
- Status last verified
- Dec 2007
- First submitted
- 31 Jan 2008
- Last updated
- 22 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Gefitinib in Benefited Patients With Asymptomatic Brain Metastasis Advanced Non-Small Cell Lung Cancer by Chemotherapy
- ClinicalTrials.gov ID
- NCT00614809
- Acronym / sponsor ID
- CSLC-0703
- Conditions
- Non-Small Cell Lung Cancer, Brain Metastasis
- Keywords
- gefitinib, brain metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Inclusion criteria:
- Histological or cytological documented stage IV NSCLC. Sputum cytology alone is excluded.
- 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.
- Patients must be at least 18 years.
- ECOG Performance Status 0, 1 or 2.
- Life expectancy of at least 12 weeks.
- Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI.
- Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L.
- Total bilirubin £ 1.5 x upper limit of normal (ULN)
- ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.
- Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula).
- PT-INR/PTT < 1.2 x ULN.
- Written informed consent.
- Able to comply with study and follow-up procedures.
Exclusion criteria:
- Mixed small cell and non-small cell lung cancer histology.
- Any unresolved toxicity>CTCAE grade 2 from previous anti-cancer therapy.
- Patients with exposure to biotherapy, immunotherapy within 4 weeks of study entry.
- Other concurrent anticancer therapy.
- Patients with exposure to investigational drug therapy outside of this trial.
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
- Any unstable systemic disease (including active infection, hepatic, renal, metabolic disease or seizure disorder requiring medication).
- 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.
- 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.
- 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].
- Pregnant or breast-feeding women.
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: gefitinibnon-randomized open-label uncontrolled phase II trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histological or cytological documented stage IV NSCLC. Sputum cytology alone is excluded
- 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.
- Patients must be at least 18 years.
- ECOG Performance Status 0, 1 or 2.
- Life expectancy of at least 12 weeks.
Key exclusion criteria (13 listed)
- Mixed small cell and non-small cell lung cancer histology.
- Any unresolved toxicity>CTCAE grade 2 from previous anti-cancer therapy.
- Patients with exposure to biotherapy, immunotherapy within 4 weeks of study entry.
- Other concurrent anticancer therapy.
- Patients with exposure to investigational drug therapy outside of this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gefitinibAlso: IRESSAgefitinib 250mg qd until disease progression or unacceptable toxicity. | Drug | 1 |
Primary outcome
Time of asymptomatic brain metastasis turn into symptomatic brain metastasis
Time frame: 12/2007~12/2010
1 secondary outcome
To determine objective response (CR+PR), time to progression, 6-month survival and 1-year survival,safety.
Time frame: 12/2007~12/2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wu yilong, MD principal investigator
Director of cancer center of Guangdong PPH
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gefitinib in people with Non-Small Cell Lung Cancer and Brain Metastasis, run by Guangdong Provincial People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of asymptomatic brain metastasis turn into symptomatic brain metastasis (time frame: 12/2007~12/2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2008.