Overview

Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

Status:
Completed

Trial end date:
2015-01-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Guangzhou Medical University

Treatments:

Cisplatin
Erlotinib Hydrochloride
Pemetrexed

Criteria

Inclusion Criteria:

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

2. 18 years or older

3. Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 3 (poor PS
caused by neurological symptom)

4. Appraisable intracranial disease, the presence of at least one lesion, and the longest
diameter > 5 mm by brain MRI

5. Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L

6. Total bilirubin 1.5 x upper limit of normal (ULN)

7. 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

8. Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)

9. If received brain radiotherapy, patients included at least 8 weeks after the end of
radiotherapy.

Exclusion Criteria:

1. Mixed non-adenocarcinoma cell lung cancer histology

2. Previous treatment with pemetrexed or tarceva

3. Be allergic to pemetrexed or tarceva