Brain MetastasesPhase 2NCT02284490
High-dose Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases
A Phase 2 study testing pemetrexed in people with Brain Metastases, run by Rongjie Tao at 1 site in China.
Trial summary
This phase II trial is studying how well pemetrexed disodium works in treating patients with Lung Adenocarcinoma With Brain Metastases Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Brain Metastases
- What is being tested?
- pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Nov 2017
- 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 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed brain metastases from lung adenocarcinoma.
- Measurable (greater than 1 cm in diameter) tumor by CT scan or MRI.
- ECOG (Eastern Cooperative Oncology Group) Performance status of 0-1.
- Measurable disease as defined by bidimensionally measurable lesions with clearly defined margins by CT scan or MRI.
- Biopsy is not required if radiographic imaging is consistent with brain metastases.
- Must have failed prior whole-brain radiotherapy.
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- Patients with leptomeningeal metastases with or without brain metastases are eligible for therapy (may be diagnosed by MRI or cytology).
- Karnofsky performance score ≥ 60
- WBC > 3,000/mm^3
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin > 10 mg/dL (transfusion allowed)
- SGOT/SGPT < 3.0 times upper limit of normal (ULN)
- Bilirubin < 1.5 times ULN
- Creatinine < 1.5 mg/dL
- Creatinine clearance > 45 mL/min
- Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study and for 3 months after completing study treatment
- Women who are pregnant or breast-feeding are not eligible for study treatment
- Negative pregnancy test
- Able to take steroids, vitamin B12, or folate
- No significant medical illnesses or infection that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
Who cannot join
- Symptomatic brain metastasis
- Have received prior radiotherapy for brain metastasis
- Unable or unwilling to take folic acid, vitamin B12 supplementation or dexamethasone (or equivalent corticosteroid); or any other inability to comply with protocol or study related procedures.
- A prior malignancy other than NSCLC, except carcinoma in situ of the cervix or non-melanoma skin cancer, adequately treated low grade [Gleason score <6] localized prostate cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence
- Serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete study.
- Inability to discontinue administration of aspirin at a dose >1.3g/day or other non-steroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days prior for long-acting agents such as piroxicam).
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- Presence of fluid accumulations in third spaces, e.g., ascite or pleural effusion, which can be detected clinically (during physical examination), and which cannot be adequately controlled by drainage or other procedures prior to inclusion in the study.
- Peripheral neuropathy > CTC Grade 2
- Patient compliance or geographic distance precluding adequate follow up.
Trial locations and contacts
1 site in 1 country.
China1 site
Neurosurgery, Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
About this study
This phase II trial is studying how well pemetrexed disodium works in treating patients with Lung Adenocarcinoma With Brain Metastases
Read the detailed description
- Determine the 6-month progression-free survival rate in patients with Lung Adenocarcinoma With Brain Metastases treated with pemetrexed disodium.
- Determine the time to progression in patients with Lung Adenocarcinoma With Brain Metastases treated with pemetrexed disodium.
Secondary
- Determine the radiographic response in patients with Lung Adenocarcinoma With Brain Metastases treated with pemetrexed disodium.
- Determine the time to response in patients treated with this drug.
- Determine the duration of response in patients treated with this drug.
- Determine the overall survival of patients treated with this drug.
- Collect safety data on patients with intracranial tumors treated with this drug.
OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
- Conditions
- Brain Metastases
- Being tested
- pemetrexed
- Keywords
- Brain Metastases
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexedDrug
Also called pemetrexed disodium, Alimta
Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Pemetrexed 900 mg/m² every 21 days until disease progression. Receives: Drug: pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the 6-month progression-free survival rate in patients with brain metastases from lung adenocarcinoma treated with pemetrexed disodium.
Measured: 1.5 years
Secondary outcomes (5)
Determine the radiographic response in patients with brain metastases from lung adenocarcinoma treated with pemetrexed disodium.
Measured: 2 years
Determine the time to response in patients treated with this drug.
Measured: 2 years
Determine the duration of response in patients treated with this drug.
Measured: 2 years
Determine the overall survival of patients treated with this drug.
Measured: 2 years
Collect safety data on patients with brain metastases from lung adenocarcinoma treated with this drug.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2016 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Brain MetastasesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rongjie Tao
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor-investigator, Rongjie Tao, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284490
- Sponsor's protocol ID
- ShandongCHI003
- Other IDs
- ShandongCHI
- Status last verified
- Nov 2014
- First submitted
- 10 Oct 2014
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bailon O, Chouahnia K, Augier A, Bouillet T, Billot S, Coman I, Ursu R, Belin C, Zelek L, Des Guetz G, Levy C, Carpentier AF, Morere JF. Upfront association of carboplatin plus pemetrexed in patients with brain metastases of lung adenocarcinoma. Neuro Oncol. 2012 Apr;14(4):491-5. doi: 10.1093/neuonc/nos004. Epub 2012 Feb 22.
PubMed 22362813Ito S, Ogawa Y, Harada H, Yamaguchi T, Munakata K. [Long-term survival of patient with brain metastases from lung cancer treated by pemetrexed monotherapy]. Gan To Kagaku Ryoho. 2012 May;39(5):793-6. Japanese.
PubMed 22584333Dinglin XX, Huang Y, Liu H, Zeng YD, Hou X, Chen LK. Pemetrexed and cisplatin combination with concurrent whole brain radiotherapy in patients with brain metastases of lung adenocarcinoma: a single-arm phase II clinical trial. J Neurooncol. 2013 May;112(3):461-6. doi: 10.1007/s11060-013-1079-5. Epub 2013 Feb 19.
PubMed 23420398Zhuang H, Yuan Z, Wang J, Zhao L, Pang Q, Wang P. Phase II study of whole brain radiotherapy with or without erlotinib in patients with multiple brain metastases from lung adenocarcinoma. Drug Des Devel Ther. 2013 Oct 8;7:1179-86. doi: 10.2147/DDDT.S53011. eCollection 2013.
PubMed 24133369Yang H, Yang X, Zhang Y, Liu X, Deng Q, Zhao M, Xu X, He J. Erlotinib in combination with pemetrexed/cisplatin for leptomeningeal metastases and cerebrospinal fluid drug concentrations in lung adenocarcinoma patients after gefitinib faliure. Target Oncol. 2015 Mar;10(1):135-40. doi: 10.1007/s11523-014-0326-9. Epub 2014 Jul 2.
PubMed 24985049
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases
- ClinicalTrials.gov ID
- NCT02284490
- Acronym / sponsor ID
- ShandongCHI003
- Conditions
- Brain Metastases
- Keywords
- Brain Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Rongjie TaoUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Nov 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 6 Nov 2014 (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 phase II trial is studying how well pemetrexed disodium works in treating patients with Lung Adenocarcinoma With Brain Metastases
Detailed description
- Determine the 6-month progression-free survival rate in patients with Lung Adenocarcinoma With Brain Metastases treated with pemetrexed disodium.
- Determine the time to progression in patients with Lung Adenocarcinoma With Brain Metastases treated with pemetrexed disodium.
Secondary
- Determine the radiographic response in patients with Lung Adenocarcinoma With Brain Metastases treated with pemetrexed disodium.
- Determine the time to response in patients treated with this drug.
- Determine the duration of response in patients treated with this drug.
- Determine the overall survival of patients treated with this drug.
- Collect safety data on patients with intracranial tumors treated with this drug.
OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: pemetrexedPemetrexed 900 mg/m² every 21 days until disease progression. |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically confirmed brain metastases from lung adenocarcinoma.
- Measurable (greater than 1 cm in diameter) tumor by CT scan or MRI.
- ECOG (Eastern Cooperative Oncology Group) Performance status of 0-1.
- Measurable disease as defined by bidimensionally measurable lesions with clearly defined margins by CT scan or MRI.
- Biopsy is not required if radiographic imaging is consistent with brain metastases.
Key exclusion criteria (9 listed)
- Symptomatic brain metastasis
- Have received prior radiotherapy for brain metastasis
- Unable or unwilling to take folic acid, vitamin B12 supplementation or dexamethasone (or equivalent corticosteroid); or any other inability to comply with protocol or study related procedures.
- A prior malignancy other than NSCLC, except carcinoma in situ of the cervix or non-melanoma skin cancer, adequately treated low grade [Gleason score <6] localized prostate cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence
- Serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete study.
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 |
|---|---|---|
| pemetrexedAlso: pemetrexed disodium, AlimtaAdministered intravenously at a dose of 900 mg/m2 every 21 days until disease progression. | Drug | Treatment Arm |
Primary outcome
Determine the 6-month progression-free survival rate in patients with brain metastases from lung adenocarcinoma treated with pemetrexed disodium.
Time frame: 1.5 years
5 secondary outcomes
Determine the radiographic response in patients with brain metastases from lung adenocarcinoma treated with pemetrexed disodium.
Time frame: 2 years
Determine the time to response in patients treated with this drug.
Time frame: 2 years
Determine the duration of response in patients treated with this drug.
Time frame: 2 years
Determine the overall survival of patients treated with this drug.
Time frame: 2 years
Collect safety data on patients with brain metastases from lung adenocarcinoma treated with this drug.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
- Results publication: PubMed 22362813Bailon O, Chouahnia K, Augier A, Bouillet T, Billot S, Coman I, Ursu R, Belin C, Zelek L, Des Guetz G, Levy C, Carpentier AF, Morere JF. Upfront association of carboplatin plus pemetrexed in patients with brain metastases of lung adenocarcinoma. Neuro Oncol. 2012 Apr;14(4):491-5. doi: 10.1093/neuonc/nos004. Epub 2012 Feb 22.
- Results publication: PubMed 22584333Ito S, Ogawa Y, Harada H, Yamaguchi T, Munakata K. [Long-term survival of patient with brain metastases from lung cancer treated by pemetrexed monotherapy]. Gan To Kagaku Ryoho. 2012 May;39(5):793-6. Japanese.
- Results publication: PubMed 23420398Dinglin XX, Huang Y, Liu H, Zeng YD, Hou X, Chen LK. Pemetrexed and cisplatin combination with concurrent whole brain radiotherapy in patients with brain metastases of lung adenocarcinoma: a single-arm phase II clinical trial. J Neurooncol. 2013 May;112(3):461-6. doi: 10.1007/s11060-013-1079-5. Epub 2013 Feb 19.
- Results publication: PubMed 24133369Zhuang H, Yuan Z, Wang J, Zhao L, Pang Q, Wang P. Phase II study of whole brain radiotherapy with or without erlotinib in patients with multiple brain metastases from lung adenocarcinoma. Drug Des Devel Ther. 2013 Oct 8;7:1179-86. doi: 10.2147/DDDT.S53011. eCollection 2013.
- Results publication: PubMed 24985049Yang H, Yang X, Zhang Y, Liu X, Deng Q, Zhao M, Xu X, He J. Erlotinib in combination with pemetrexed/cisplatin for leptomeningeal metastases and cerebrospinal fluid drug concentrations in lung adenocarcinoma patients after gefitinib faliure. Target Oncol. 2015 Mar;10(1):135-40. doi: 10.1007/s11523-014-0326-9. Epub 2014 Jul 2.
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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.
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 pemetrexed in people with Brain Metastases, run by Rongjie Tao 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 21 inclusion and 9 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 6 Nov 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Wang, M.D (+6813365318361, doctorwy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the 6-month progression-free survival rate in patients with brain metastases from lung adenocarcinoma treated with pemetrexed disodium. (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02284490, which also lists 5 linked publications.
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 6 Nov 2014.