Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Lung Adenocarcinoma; Brain Metastases	Drug: erlotinib; Drug: pemetrexed; Drug: cisplatin	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	69 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase 2 Study of Erlotinib Plus Pemetrexed/Cisplatin Treating Lung Adenocarcinoma With Brain Metastases
Study Start Date :	January 2012
Actual Primary Completion Date :	January 2015
Actual Study Completion Date :	January 2015

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Erlotinib, pemetrexed, cisplatin	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; Other Name: Tarceva Drug: 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; Other Name: ALIMTA Drug: 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; Other Name: platinum
Experimental: erlotinib	Drug: erlotinib; 150 mg given orally (po), daily (QD), starting on the first day of the first cycle; Other Name: Tarceva

Outcome Measures

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Primary Outcome Measures :

1. The objective response rate of brain metastases [ Time Frame: Patients will be followed for an expected average of 6 weeks ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

China, Guangdong
The first affiliated hospital of Guangzhou MC
Guangzhou, Guangdong, China, 510120

Sponsors and Collaborators

Guangzhou Medical University

Investigators

Principal Investigator:	Haihong Yang, Dr.	The first affiliated hospital of Guangzhou MC

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Haihong Yang, MD, Pricipal investigator, The first affiliated hospital of Guangzhou MC, Guangzhou Medical University
ClinicalTrials.gov Identifier:	NCT01578668 History of Changes
Other Study ID Numbers:	GZTO1201
First Posted:	April 17, 2012
Last Update Posted:	January 26, 2015
Last Verified:	January 2015

Keywords provided by Haihong Yang, MD, Pricipal investigator, Guangzhou Medical University:

lung adenocarcinoma; brain metastases; erlotinib; pemetrexed

Additional relevant MeSH terms:

Adenocarcinoma; Neoplasm Metastasis; Neoplasms, Second Primary; Brain Neoplasms; Lung Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Pathologic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases	Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Cisplatin; Erlotinib Hydrochloride; Pemetrexed; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors