Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

Phase 2

Completed

• Conditions: Lung Adenocarcinoma; Brain Metastases
• Interventions: Drug: erlotinib; Drug: pemetrexed; Drug: cisplatin

• Registration Number: NCT01578668
• Lead Sponsor: Guangzhou Medical University

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-17
• Status Verified: 2015-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-23
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erlotinib, pemetrexed, cisplatin	cisplatin	-
Erlotinib, pemetrexed, cisplatin	pemetrexed	-
Erlotinib, pemetrexed, cisplatin	erlotinib	-
erlotinib	erlotinib	-

Primary Outcome Measures

Name	Time	Method
The objective response rate of brain metastases	Patients will be followed for an expected average of 6 weeks

Secondary Outcome Measures

Name	Time	Method
Overall survival of patients	3 years after the first treatment
The disease control response rate of disease	Patients will be followed for an expected average of 6 weeks
Number of participants with adverse events as a measure of safety	2 years after first treatment
Progression-free survival of patients	2 years after first treatment

Trial Locations

Locations (1)

The first affiliated hospital of Guangzhou MC; 🇨🇳 Guangzhou, Guangdong, China