NCT01578668

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

3 years

First QC Date

April 11, 2012

Last Update Submit

January 23, 2015

Conditions

Lung AdenocarcinomaBrain Metastases

Keywords

lung adenocarcinomabrain metastaseserlotinibpemetrexed

Outcome Measures

Primary Outcomes (1)

  • The objective response rate of brain metastases

    Patients will be followed for an expected average of 6 weeks

Secondary Outcomes (4)

  • The disease control response rate of disease

    Patients will be followed for an expected average of 6 weeks

  • Progression-free survival of patients

    2 years after first treatment

  • Number of participants with adverse events as a measure of safety

    2 years after first treatment

  • Overall survival of patients

    3 years after the first treatment

Study Arms (2)

Erlotinib, pemetrexed, cisplatin

EXPERIMENTAL
Drug: erlotinibDrug: pemetrexedDrug: cisplatin

erlotinib

EXPERIMENTAL
Drug: erlotinib

Interventions

erlotinibDRUG

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

Also known as: Tarceva
Erlotinib, pemetrexed, cisplatin
pemetrexedDRUG

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

Also known as: ALIMTA
Erlotinib, pemetrexed, cisplatin
cisplatinDRUG

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

Also known as: platinum
Erlotinib, pemetrexed, cisplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological or cytological diagnosis of lung adenocarcinoma histology with brain metastases
  • 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)
  • 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.

You may not qualify if:

  • Mixed non-adenocarcinoma cell lung cancer histology
  • Previous treatment with pemetrexed or tarceva
  • Be allergic to pemetrexed or tarceva

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital of Guangzhou MC

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Adenocarcinoma of LungBrain Neoplasms

Interventions

Erlotinib HydrochloridePemetrexedCisplatinPlatinum

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGuanineHypoxanthinesPurinonesPurinesGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsMetals, HeavyElementsTransition ElementsMetals

Study Officials

  • Haihong Yang, Dr.

    The first affiliated hospital of Guangzhou MC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The first affiliated hospital of Guangzhou MC

Study Record Dates

First Submitted

April 11, 2012

First Posted

April 17, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 26, 2015

Record last verified: 2015-01

Locations

CN(1)