NCT02284490

Brief Summary

This phase II trial is studying how well pemetrexed disodium works in treating patients with Lung Adenocarcinoma With Brain Metastases

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 6, 2014

Status Verified

November 1, 2014

Enrollment Period

1.9 years

First QC Date

October 10, 2014

Last Update Submit

November 3, 2014

Conditions

Brain Metastases

Keywords

Brain Metastases

Outcome Measures

Primary Outcomes (1)

  • Determine the 6-month progression-free survival rate in patients with brain metastases from lung adenocarcinoma treated with pemetrexed disodium.

    1.5 years

Secondary Outcomes (5)

  • Determine the radiographic response in patients with brain metastases from lung adenocarcinoma treated with pemetrexed disodium.

    2 years

  • Determine the time to response in patients treated with this drug.

    2 years

  • Determine the duration of response in patients treated with this drug.

    2 years

  • Determine the overall survival of patients treated with this drug.

    2 years

  • Collect safety data on patients with brain metastases from lung adenocarcinoma treated with this drug.

    2 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Pemetrexed 900 mg/m² every 21 days until disease progression.

Drug: pemetrexed

Interventions

pemetrexedDRUG

Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.

Also known as: pemetrexed disodium, Alimta
Treatment Arm

Eligibility Criteria

Age20 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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
  • +6 more criteria

You may not qualify if:

  • 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).
  • Peripheral neuropathy \> CTC Grade 2
  • Patient compliance or geographic distance precluding adequate follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurosurgery, Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

Location

Related Publications (5)

  • 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.

    PMID: 22362813RESULT

  • Ito 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.

    PMID: 22584333RESULT

  • Dinglin 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.

    PMID: 23420398RESULT

  • Zhuang 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.

    PMID: 24133369RESULT

  • Yang 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.

    PMID: 24985049RESULT

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Central Study Contacts

Yong Wang, M.D

CONTACT

+6813365318361doctorwy@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Neurosurgery

Study Record Dates

First Submitted

October 10, 2014

First Posted

November 6, 2014

Study Start

November 1, 2014

Primary Completion

October 1, 2016

Study Completion

November 1, 2017

Last Updated

November 6, 2014

Record last verified: 2014-11

Locations

CN(1)