Leptomeningeal CarcinomatosisPhase 2NCT00830245
A Study to Assess the Efficacy of Erlotinib for Leptomeningeal Carcinomatosis in EGFR Mutation Positive Non-small Cell Lung Cancer
A Phase 2 study testing Erlotinib in people with Leptomeningeal Carcinomatosis and Non-small Cell Lung Cancer, run by Clinical Research Center for Solid Tumor, Korea at 1 site in South Korea.
Trial summary
To assess the efficacy and safety of erlotinib for non-small cell lung cancer patients with leptomeningeal carcinomatosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptomeningeal Carcinomatosis, Non-small Cell Lung Cancer
- What is being tested?
- Erlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Jul 2011
- 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
- Age >18
- Histologically or pathologically proven non-small cell lung cancer (NSCLC)
- Leptomeningeal carcinomatosis confirmed by CSF cytology
- A patients with EGFR mutation (including exon 19 deletion, L858R)
- ECOG performance status 0-3
- Expected life time more than at least 4 weeks
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- A patients who signed the informed consent prior to the participation in the study
- Chemotherapy-naïve patient is eligible
- Previous EGFR TKI is allowed if this drug was not specifically used for CNS metastases
Who cannot join
- A pregnant or lactating patient
- A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
- A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
- A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
- A patient with active interstitial lung disease, except simple lymphangitic lung metastasis
- A patient with history of allergic reaction to gefitinib or erlotinib
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- The following laboratory test results:
- Number of absolute neutrophils counts (ANC) < 1.0ⅹ109/L
- Number of platelets < 50 ⅹ109/L
- AST, ALT > 2.5 ⅹupper limit of normal
- Total bilirubin > 1.5 ⅹupper limit of normal
- Serum creatinine > 1.5 ⅹupper limit of normal
- A patient with serious disease as followings
- Uncontrolled cardiac arrhythmia
- History of myocardial infarction within 6 months prior to the initiation of study
- Neurological or psychiatric disorder including dementia or uncontrolled seizure
- A patient who refused to sign the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
To assess the efficacy and safety of erlotinib for non-small cell lung cancer patients with leptomeningeal carcinomatosis
- Being tested
- Erlotinib
- Keywords
- EGFR mutation, Erlotinib, Lung cancer, leptomeningeal carcinomatosis in EGFR mutation positive non-small cell lung cancer
- Medical subject headings
- Meningeal Carcinomatosis, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Erlotinib 150mg/day
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib | Experimental | Erlotinib 150mg/day (if no negative conversion --> increment to 250mg/day) Receives: Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 1 year
Secondary outcomes (7)
Cytology negative conversion rate
Measured: 1 month, 2 months, 3 months, 4 months
Neurologic symptom improvement
Measured: 1 month, 2 months, 3 months, 4 months
Response rate (extra-cranial disease)
Measured: 2 months, 4 months
Response rate (brain)
Measured: 2 months, 4 months
Quality of life
Measured: 1 month, 2 months, 3 months, 4 months
Toxicities
Measured: 1 month, 2 months, 3 months, 4 months
Prognostic factors
Measured: N-A
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: low accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leptomeningeal CarcinomatosisStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Research Center for Solid Tumor, Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Korean Cancer Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830245
- Sponsor's protocol ID
- CRCST-L-0005
- Status last verified
- Jul 2011
- First submitted
- 24 Jan 2009
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Efficacy of Erlotinib for Leptomeningeal Carcinomatosis in EGFR Mutation Positive Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00830245
- Acronym / sponsor ID
- CRCST-L-0005
- Keywords
- EGFR mutation, Erlotinib, Lung cancer, leptomeningeal carcinomatosis in EGFR mutation positive non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual rate
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Clinical Research Center for Solid Tumor, KoreaUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Korean Cancer Study Group
- Study start
- Jan 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Jan 2009 (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.
To assess the efficacy and safety of erlotinib for non-small cell lung cancer patients with leptomeningeal carcinomatosis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erlotinib | Experimental | Drug: ErlotinibErlotinib 150mg/day (if no negative conversion --> increment to 250mg/day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >18
- Histologically or pathologically proven non-small cell lung cancer (NSCLC)
- Leptomeningeal carcinomatosis confirmed by CSF cytology
- A patients with EGFR mutation (including exon 19 deletion, L858R)
- ECOG performance status 0-3
Key exclusion criteria (17 listed)
- A pregnant or lactating patient
- A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
- A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
- A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
- A patient with active interstitial lung disease, except simple lymphangitic lung metastasis
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 |
|---|---|---|
| ErlotinibErlotinib 150mg/day | Drug | Erlotinib |
Primary outcome
Overall survival
Time frame: 1 year
7 secondary outcomes
Cytology negative conversion rate
Time frame: 1 month, 2 months, 3 months, 4 months
Neurologic symptom improvement
Time frame: 1 month, 2 months, 3 months, 4 months
Response rate (extra-cranial disease)
Time frame: 2 months, 4 months
Response rate (brain)
Time frame: 2 months, 4 months
Quality of life
Time frame: 1 month, 2 months, 3 months, 4 months
Toxicities
Time frame: 1 month, 2 months, 3 months, 4 months
Prognostic factors
Time frame: N-A
Results and safety
The study was stopped early (reason given: low accrual rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib in people with Leptomeningeal Carcinomatosis and Non-small Cell Lung Cancer, run by Clinical Research Center for Solid Tumor, Korea at 1 site in South Korea.
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 9 inclusion and 17 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: stopped early, as of the sponsor's last update on 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: low accrual rate). 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?
Overall survival (time frame: 1 year). 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 26 Jul 2011.