Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01578668
Recruitment Status : Completed
First Posted : April 17, 2012
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Haihong Yang, MD, Pricipal investigator, Guangzhou Medical University

Tracking Information
First Submitted Date  ICMJE April 11, 2012
First Posted Date  ICMJE April 17, 2012
Last Update Posted Date January 26, 2015
Study Start Date  ICMJE January 2012
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2012)
The objective response rate of brain metastases [ Time Frame: Patients will be followed for an expected average of 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2012)
  • 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 ]
  • Qualities on the Function Assess Cancer Treatment-Lung (FACT-L) [ Time Frame: 2 years after first treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases
Official Title  ICMJE Phase 2 Study of Erlotinib Plus Pemetrexed/Cisplatin Treating Lung Adenocarcinoma With Brain Metastases
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Adenocarcinoma
  • Brain Metastases
Intervention  ICMJE
  • 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
  • Drug: erlotinib
    150 mg given orally (po), daily (QD), starting on the first day of the first cycle
    Other Name: Tarceva
Study Arms  ICMJE
  • Experimental: Erlotinib, pemetrexed, cisplatin
    Interventions:
    • Drug: erlotinib
    • Drug: pemetrexed
    • Drug: cisplatin
  • Experimental: erlotinib
    Intervention: Drug: erlotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2015)
69
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2012)
90
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01578668
Other Study ID Numbers  ICMJE GZTO1201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Haihong Yang, MD, Pricipal investigator, Guangzhou Medical University
Study Sponsor  ICMJE Guangzhou Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Haihong Yang, Dr. The first affiliated hospital of Guangzhou MC
PRS Account Guangzhou Medical University
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP