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Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

Primary Purpose

Lung Adenocarcinoma, Brain Metastases

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

erlotinib

pemetrexed

cisplatin

erlotinib

About this trial

This is an interventional treatment trial for Lung Adenocarcinoma focused on measuring lung adenocarcinoma, brain metastases, erlotinib, pemetrexed

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The first affiliated hospital of Guangzhou MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Erlotinib, pemetrexed, cisplatin

erlotinib

Arm Description

Outcomes

Primary Outcome Measures

The objective response rate of brain metastases

Secondary Outcome Measures

The disease control response rate of disease

Progression-free survival of patients

Number of participants with adverse events as a measure of safety

Overall survival of patients

Full Information

NCT ID

NCT01578668

First Posted

April 11, 2012

Last Updated

January 23, 2015

Sponsor

Guangzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01578668

Brief Title

Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

Official Title

Phase 2 Study of Erlotinib Plus Pemetrexed/Cisplatin Treating Lung Adenocarcinoma With Brain Metastases

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangzhou Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Adenocarcinoma, Brain Metastases

Keywords

lung adenocarcinoma, brain metastases, erlotinib, pemetrexed

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Erlotinib, pemetrexed, cisplatin

Arm Type

Experimental

Arm Title

erlotinib

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

erlotinib

Other Intervention Name(s)

Tarceva

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

pemetrexed

Other Intervention Name(s)

ALIMTA

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

cisplatin

Other Intervention Name(s)

platinum

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

erlotinib

Other Intervention Name(s)

Tarceva

Intervention Description

150 mg given orally (po), daily (QD), starting on the first day of the first cycle

Primary Outcome Measure Information:

Title

The objective response rate of brain metastases

Time Frame

Patients will be followed for an expected average of 6 weeks

Secondary Outcome Measure Information:

Title

The disease control response rate of disease

Time Frame

Patients will be followed for an expected average of 6 weeks

Title

Progression-free survival of patients

Time Frame

2 years after first treatment

Title

Number of participants with adverse events as a measure of safety

Time Frame

2 years after first treatment

Title

Overall survival of patients

Time Frame

3 years after the first treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haihong Yang, Dr.

Organizational Affiliation

The first affiliated hospital of Guangzhou MC

Official's Role

Principal Investigator

Facility Information:

Facility Name

The first affiliated hospital of Guangzhou MC

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

12. IPD Sharing Statement

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Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

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