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Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients

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: NCT01783834
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
Eun Kyung Cho, Gachon University Gil Medical Center

Study Description
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Brief Summary:
To compare the efficacy of gefitinib versus pemetrexed as second-line chemotherapy for patients with previous treated non-small cell lung cancer

Condition or disease Intervention/treatment Phase
Previous Treated Metastatic Non-small Cell Lung Cancer Drug: Gefitinib Drug: Pemetrexed Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Pemetrexed Versus Gefitinib in Previously Treated Patients With Advanced Non-small Cell Lung Cancer
Study Start Date : February 2008
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: pemetrexed
pemetrexed
 Drug: Pemetrexed
compare PFS rate, safety to both drugs
Other Name: alimta
Active Comparator: gefitinib
gefitinib
 Drug: Gefitinib
compare progression free survivla rate and safety to both drugs
Other Name: irressa


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 5years ]

Other Outcome Measures:
  1. Number of participants with adverse events [ Time Frame: 5years ]

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

Inclusion Criteria:

  • Cells pathologically diagnosed as histological or radical surgery or radiation therapy is not possible stage IIIB and stage IV non-small-cell lung cancer patients
  • second line
  • ECOG 0～2
  • Patients with normal liver function and renal function

Exclusion Criteria:

  • Patients with severe acute infection requiring antibiotic therapy
  • Patients who have received treatment in other areas of cancer within 5 years
  • During pregnancy and lactation patients
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01783834


Locations
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Korea, Republic of
Gachon university Gil Medical Center
Incheon, Korea, Republic of
Sponsors and Collaborators
Gachon University Gil Medical Center
More Information
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Responsible Party: Eun Kyung Cho, professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01783834    
Other Study ID Numbers: 2008-GIRBA-1739
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016
Keywords provided by Eun Kyung Cho, Gachon University Gil Medical Center:
Pemetrexed
Gefitinib
iressa
alimta
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Pemetrexed
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors