Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma Wi... | NCT01578668

Studies
Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

NCT01578668

Sponsor

Guangzhou Medical University

Status

Completed

Last Update Posted

Jan 26, 2015Estimated

Enrollment

69Actual

Phase

Phase 2

Conditions

Lung Adenocarcinoma
Brain Metastases

Interventions

erlotinib
pemetrexed
cisplatin
erlotinib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Apr 11, 2012

First Submission Date that Met QC Criteria

Apr 16, 2012

First Posted Date

Apr 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2015

Last Update Posted Date

Jan 26, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Haihong Yang, MD, Pricipal investigator, The first affiliated hospital of Guangzhou MC, Guangzhou Medical UniversityPrincipal Investigator

Lead Sponsor

Guangzhou Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Erlotinib, pemetrexed, cisplatin	Experimental		Drug: erlotinib Drug: pemetrexed Drug: cisplatin
erlotinib	Experimental		Drug: erlotinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
erlotinib	Drug	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	Erlotinib, pemetrexed, cisplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The objective response rate of brain metastases		Patients will be followed for an expected average of 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)
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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Haihong Yang, Dr.	The first affiliated hospital of Guangzhou MC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The first affiliated hospital of Guangzhou MC		Guangzhou	Guangdong	510120	China

Type	Date	Date Unknown
Release	Mar 27, 2019
Reset	Jun 20, 2019

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 27, 2019			Jun 20, 2019

Condition Browse Module

MeSH Terms

ID	Term
D000077192	Adenocarcinoma of Lung
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069347	Erlotinib Hydrochloride
D000068437	Pemetrexed
D002945	Cisplatin
D010984	Platinum

Ancestor Terms

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided