Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Guangzhou Medical University
Sponsor:
Information provided by (Responsible Party):
Haihong Yang, MD, Pricipal investigator, Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT01578668
First received: April 11, 2012
Last updated: April 8, 2014
Last verified: April 2014
  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:


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 ]

Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: January 2017
Estimated 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

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:

  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
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

Contacts
Contact: Haihong Yang, Dr. 0862083062825 bjrf2009@yahoo.com

Locations
China, Guangdong
The first affiliated hospital of Guangzhou MC Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Haihong Yang, Dr.    0862083062825    bjrf2009@yahoo.com   
Principal Investigator: Haihong Yang, Dr.         
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: April 8, 2014
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
Neoplasms, Second Primary
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

ClinicalTrials.gov processed this record on October 22, 2014