Phase 2 Study of Erlotinib Plus Pemetrexed/Cisplatin Treating Lung Adenocarcinoma With Brain Metastases
18 Years
N/A
Both
Lung Adenocarcinoma, Brain Metastases
Trial Information
Phase 2 Study of Erlotinib Plus Pemetrexed/Cisplatin Treating Lung Adenocarcinoma With Brain Metastases
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.
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 2
4. Appraisable disease, the presence of at least three lesions if longest diameter <10
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)
Exclusion Criteria:
1. Mixed non-adenocarcinoma cell lung cancer histology
2. Previous treatment for brain metastasis
3. Previous treatment with pemetrexed or tarceva
4. Be allergic to pemetrexed or tarceva
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The objective response rate of brain metastases
Outcome Time Frame:
Patients will be followed for an expected average of 6 weeks
Safety Issue:
Yes
Principal Investigator
Haihong Yang, Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
The first affiliated hospital of Guangzhou MC
Authority:
United States: Food and Drug Administration
Study ID:
GZTO1201
NCT ID:
NCT01578668
Start Date:
January 2012
Completion Date:
January 2017
Related Keywords:
- Lung Adenocarcinoma
- Brain Metastases
- lung adenocarcinoma
- brain metastases
- erlotinib
- pemetrexed
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Lung Neoplasms
- Brain Neoplasms
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