Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

Guangzhou Medical University

Status and phase: Completed; Phase 2

Conditions: Brain Metastases; Lung Adenocarcinoma

Treatments: Drug: cisplatin; Drug: erlotinib; Drug: pemetrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT01578668

GZTO1201

Details and patient eligibility

About

The purpose of this study is to determine whether erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

Erlotinib, pemetrexed, cisplatin

Experimental group

Treatment:

Drug: erlotinib

Drug: pemetrexed

Drug: erlotinib

Drug: cisplatin

erlotinib

Experimental group

Treatment:

Drug: erlotinib

Drug: erlotinib