Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

Brain Metastases Clinical Trial

Official title:

Phase 2 Study of Erlotinib Plus Pemetrexed/Cisplatin Treating Lung Adenocarcinoma With Brain Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578668
• Other study ID #: GZTO1201
• Status: Completed
• Phase: Phase 2
• First received: April 11, 2012
• Last updated: January 23, 2015
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Brain Metastases
• Brain Neoplasms
• Lung Adenocarcinoma
• Lung Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• erlotinib
150 mg given orally (po), daily (QD), starting on the 4th day of each cycle, ending on the 21th day before the next cycle, and until disease PD
• pemetrexed
500 mg/m² intravenous (iv) over 15 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity or no more than 6 cycles
• cisplatin
cisplatin 20mg/m² iv on the 1st-3rd day (if PS<2) or 30 mg iv on the 1st-2nd day (if PS=2 or 3)of each cycle until PD or unacceptable toxicity or no more than 6 cycles
• erlotinib
150 mg given orally (po), daily (QD), starting on the first day of the first cycle

Locations

Country	Name	City	State
China	The first affiliated hospital of Guangzhou MC	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The objective response rate of brain metastases		Patients will be followed for an expected average of 6 weeks	Yes
Secondary	The disease control response rate of disease		Patients will be followed for an expected average of 6 weeks	Yes
Secondary	Progression-free survival of patients		2 years after first treatment	Yes
Secondary	Number of participants with adverse events as a measure of safety		2 years after first treatment	Yes
Secondary	Overall survival of patients		3 years after the first treatment	Yes