Clinical trial NCT01578668: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Adenocarcinoma
Brain Metastases
Keywords: lung adenocarcinoma
brain metastases
erlotinib
pemetrexed
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The objective response rate of brain metastases
timeFrame: Patients will be followed for an expected average of 6 weeks
Secondary outcomes:
measure: The disease control response rate of disease
timeFrame: Patients will be followed for an expected average of 6 weeks
measure: Progression-free survival of patients
timeFrame: 2 years after first treatment
measure: Number of participants with adverse events as a measure of safety
timeFrame: 2 years after first treatment
measure: Overall survival of patients
timeFrame: 3 years after the first treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The first affiliated hospital of Guangzhou MC
state: Guangdong
Study officials:
affiliation: The first affiliated hospital of Guangzhou MC
name: Haihong Yang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: