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Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients

This study is currently recruiting participants.
Verified February 2013 by Gachon University Gil Medical Center
Sponsor:
Information provided by (Responsible Party):
Eun Kyung Cho, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01783834
First received: January 30, 2013
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 5years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 5years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 116
Study Start Date: February 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pemetrexed
pemetrexed
 Drug: Pemetrexed
Active Comparator: gefitinib
gefitinib
 Drug: Gefitinib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783834

Contacts
Contact: Hee Kyung Ahn, professor +82-32-460-2625 hkahn@gilhospital.com

Locations
Korea, Republic of
Gachon university Gil Medical Center Recruiting
Incheon, Korea, Republic of
Contact: HeeKyung Ahn, professor     +82-32-460-2625     hkahn@gilhospital.com    
Sponsors and Collaborators
Gachon University Gil Medical Center
  More Information

No publications provided

Responsible Party: Eun Kyung Cho, professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01783834     History of Changes
Other Study ID Numbers: 2008-GIRBA-1739
Study First Received: January 30, 2013
Last Updated: February 4, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Gachon University Gil Medical Center:
Pemetrexed
Gefitinib
iressa
alimta

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
 Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013