Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases
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ClinicalTrials.gov Identifier: NCT01578668 |
Recruitment Status :
Completed
First Posted : April 17, 2012
Last Update Posted : January 26, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Adenocarcinoma Brain Metastases | Drug: erlotinib Drug: pemetrexed Drug: cisplatin | Phase 2 |
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 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological or cytological diagnosis of lung adenocarcinoma histology with brain metastases
- 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 3 (poor PS caused by neurological symptom)
- Appraisable intracranial disease, the presence of at least one lesion, and the longest diameter > 5 mm by brain MRI
- Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L
- Total bilirubin 1.5 x upper limit of normal (ULN)
- 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
- Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
- If received brain radiotherapy, patients included at least 8 weeks after the end of radiotherapy.
Exclusion Criteria:
- Mixed non-adenocarcinoma cell lung cancer histology
- Previous treatment with pemetrexed or tarceva
- Be allergic to pemetrexed or tarceva

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578668
China, Guangdong | |
The first affiliated hospital of Guangzhou MC | |
Guangzhou, Guangdong, China, 510120 |
Principal Investigator: | Haihong Yang, Dr. | The first affiliated hospital of Guangzhou MC |
Responsible Party: | Haihong Yang, MD, Pricipal investigator, The first affiliated hospital of Guangzhou MC, Guangzhou Medical University |
ClinicalTrials.gov Identifier: | NCT01578668 |
Other Study ID Numbers: |
GZTO1201 |
First Posted: | April 17, 2012 Key Record Dates |
Last Update Posted: | January 26, 2015 |
Last Verified: | January 2015 |
lung adenocarcinoma brain metastases erlotinib pemetrexed |
Adenocarcinoma Neoplasm Metastasis Neoplasms, Second Primary Brain Neoplasms Adenocarcinoma of Lung 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 Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Cisplatin Erlotinib Hydrochloride Pemetrexed Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |