Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 19, 2013
Last verified: August 2013
  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:


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
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: 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: August 19, 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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Gefitinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014