Lung AdenocarcinomaPhase 2NCT01578668
Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases
A Phase 2 study testing erlotinib, pemetrexed and cisplatin in people with Lung Adenocarcinoma and Brain Metastases, run by Guangzhou Medical University at 1 site in China.
Trial summary
The purpose of this study is to determine whether erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Adenocarcinoma, Brain Metastases
- What is being tested?
- erlotinib, pemetrexed and cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Jan 2015
- 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 diagnosis of lung adenocarcinoma histology with brain metastases
- 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 3 (poor PS caused by neurological symptom)
- Appraisable intracranial disease, the presence of at least one lesion, and the longest diameter > 5 mm by brain MRI
- Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L
- Total bilirubin 1.5 x upper limit of normal (ULN)
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- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
- Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
- If received brain radiotherapy, patients included at least 8 weeks after the end of radiotherapy.
Who cannot join
- Mixed non-adenocarcinoma cell lung cancer histology
- Previous treatment with pemetrexed or tarceva
- Be allergic to pemetrexed or tarceva
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of Guangzhou MC
Guangzhou, Guangdong, 510120
About this study
Official title: Phase 2 Study of Erlotinib Plus Pemetrexed/Cisplatin Treating Lung Adenocarcinoma With Brain Metastases
The purpose of this study is to determine whether erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.
Read the detailed description
Non-small lung cancer (NSCLC) is the leading cause of death in the world. Brain metastases are a frequent complication of NSCLC, especially in lung adenocarcinoma. 30-50% or more these patients will develop brain metastases at first time or during the treatment. Limited treatment options, whole brain radiotherapy (WBRT) combined with or without stereotactic radiosurgery (SRS) as the primary treatment approach, are available for brain metastases patients with poor survival. So the availability of effective therapies are therefore of great importance. Currently, two agents (erlotinib and pemetrexed) are reported more effective in lung adenocarcinoma patients with brain metastases. The heterogeneity of NSCLC tumors provides a strong rationale for using combination therapy with targeted agents that have different mechanisms of action, moreover different combination offering synergistic effects. So we investigate if erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.
- Conditions
- Lung Adenocarcinoma, Brain Metastases
- Being tested
- erlotinib, pemetrexed, cisplatin
- Keywords
- lung adenocarcinoma, brain metastases, erlotinib, pemetrexed
- Medical subject headings
- Adenocarcinoma of Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinibDrug
Also called Tarceva
150 mg given orally (po), daily (QD), starting on the 4th day of each cycle, ending on the 21th day before the next cycle, and until disease PD
pemetrexedDrug
Also called ALIMTA
500 mg/m² intravenous (iv) over 15 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity or no more than 6 cycles
cisplatinDrug
Also called platinum
cisplatin 20mg/m² iv on the 1st-3rd day (if PS<2) or 30 mg iv on the 1st-2nd day (if PS=2 or 3)of each cycle until PD or unacceptable toxicity or no more than 6 cycles
erlotinibDrug
Also called Tarceva
150 mg given orally (po), daily (QD), starting on the first day of the first cycle
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib, pemetrexed, cisplatin | Experimental | Not described Receives: Drug: erlotinib; Drug: pemetrexed; Drug: cisplatin |
| erlotinib | Experimental | Not described Receives: Drug: erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective response rate of brain metastases
Measured: Patients will be followed for an expected average of 6 weeks
Secondary outcomes (4)
The disease control response rate of disease
Measured: Patients will be followed for an expected average of 6 weeks
Progression-free survival of patients
Measured: 2 years after first treatment
Number of participants with adverse events as a measure of safety
Measured: 2 years after first treatment
Overall survival of patients
Measured: 3 years after the first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haihong Yang, MD, Pricipal investigator, Guangzhou Medical University
- Investigators
- Haihong Yang, Dr., Principal investigator, The first affiliated hospital of Guangzhou MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578668
- Sponsor's protocol ID
- GZTO1201
- Status last verified
- Jan 2015
- First submitted
- 11 Apr 2012
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Erlotinib Plus Pemetrexed/Cisplatin Treating Lung Adenocarcinoma With Brain Metastases
- ClinicalTrials.gov ID
- NCT01578668
- Acronym / sponsor ID
- GZTO1201
- Conditions
- Lung Adenocarcinoma, Brain Metastases
- Keywords
- lung adenocarcinoma, brain metastases, erlotinib, pemetrexed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Apr 2012 (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.
The purpose of this study is to determine whether erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.
Detailed description
Non-small lung cancer (NSCLC) is the leading cause of death in the world. Brain metastases are a frequent complication of NSCLC, especially in lung adenocarcinoma. 30-50% or more these patients will develop brain metastases at first time or during the treatment. Limited treatment options, whole brain radiotherapy (WBRT) combined with or without stereotactic radiosurgery (SRS) as the primary treatment approach, are available for brain metastases patients with poor survival. So the availability of effective therapies are therefore of great importance. Currently, two agents (erlotinib and pemetrexed) are reported more effective in lung adenocarcinoma patients with brain metastases. The heterogeneity of NSCLC tumors provides a strong rationale for using combination therapy with targeted agents that have different mechanisms of action, moreover different combination offering synergistic effects. So we investigate if erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erlotinib, pemetrexed, cisplatin | Experimental | Drug: erlotinib, Drug: pemetrexed, Drug: cisplatin |
| erlotinib | Experimental | Drug: erlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histological or cytological diagnosis of lung adenocarcinoma histology with brain metastases
- 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 3 (poor PS caused by neurological symptom)
- Appraisable intracranial disease, the presence of at least one lesion, and the longest diameter > 5 mm by brain MRI
- Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L
Key exclusion criteria (3 listed)
- Mixed non-adenocarcinoma cell lung cancer histology
- Previous treatment with pemetrexed or tarceva
- Be allergic to pemetrexed or tarceva
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 |
|---|---|---|
| erlotinibAlso: Tarceva150 mg given orally (po), daily (QD), starting on the 4th day of each cycle, ending on the 21th day before the next cycle, and until disease PD | Drug | Erlotinib, pemetrexed, cisplatin |
| pemetrexedAlso: ALIMTA500 mg/m² intravenous (iv) over 15 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity or no more than 6 cycles | Drug | Erlotinib, pemetrexed, cisplatin |
| cisplatinAlso: platinumcisplatin 20mg/m² iv on the 1st-3rd day (if PS<2) or 30 mg iv on the 1st-2nd day (if PS=2 or 3)of each cycle until PD or unacceptable toxicity or no more than 6 cycles | Drug | Erlotinib, pemetrexed, cisplatin |
| erlotinibAlso: Tarceva150 mg given orally (po), daily (QD), starting on the first day of the first cycle | Drug | erlotinib |
Primary outcome
The objective response rate of brain metastases
Time frame: Patients will be followed for an expected average of 6 weeks
4 secondary outcomes
The disease control response rate of disease
Time frame: Patients will be followed for an expected average of 6 weeks
Progression-free survival of patients
Time frame: 2 years after first treatment
Number of participants with adverse events as a measure of safety
Time frame: 2 years after first treatment
Overall survival of patients
Time frame: 3 years after the first treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
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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.
Haihong Yang, Dr. principal investigator
The first affiliated hospital of Guangzhou MC
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, pemetrexed and cisplatin in people with Lung Adenocarcinoma and Brain Metastases, run by Guangzhou Medical University at 1 site in China.
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 3 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: finished, as of the sponsor's last update on 26 Jan 2015. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The objective response rate of brain metastases (time frame: Patients will be followed for an expected average of 6 weeks). 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 Jan 2015.