Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases - Full Text View

Purpose

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	Intervention	Phase
Lung Adenocarcinoma Brain Metastases	Drug: erlotinib Drug: pemetrexed Drug: cisplatin	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 2 Study of Erlotinib Plus Pemetrexed/Cisplatin Treating Lung Adenocarcinoma With Brain Metastases

Resource links provided by NLM:

Drug Information available for: Cisplatin Pemetrexed Pemetrexed disodium Erlotinib hydrochloride Erlotinib

Genetic and Rare Diseases Information Center resources: Adenocarcinoma of Lung

U.S. FDA Resources

Further study details as provided by Guangzhou Medical University:

Primary Outcome Measures:

The objective response rate of brain metastases [ Time Frame: Patients will be followed for an expected average of 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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


Enrollment:	69
Study Start Date:	January 2012
Study Completion Date:	January 2015
Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578668

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

No publications provided


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
Study First Received:	April 11, 2012
Last Updated:	January 23, 2015
Health Authority:	United States: Food and Drug Administration China: Food and Drug Administration

Keywords provided by Guangzhou Medical University:


lung adenocarcinoma brain metastases erlotinib pemetrexed

Additional relevant MeSH terms:


Adenocarcinoma Brain Neoplasms Lung Neoplasms Neoplasm Metastasis Brain Diseases Carcinoma Central Nervous System Diseases Central Nervous System Neoplasms Lung Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Nervous System Diseases	Nervous System Neoplasms Pathologic Processes Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Cisplatin Erlotinib Pemetrexed Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions

ClinicalTrials.gov processed this record on March 02, 2015