Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients

This study has been completed.

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 10, 2016

Last verified: February 2016

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 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

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Pemetrexed Pemetrexed disodium Gefitinib

U.S. FDA Resources

Further study details as provided by Eun Kyung Cho, Gachon University Gil Medical Center:

Primary Outcome Measures:

Overall response rate [ Time Frame: 5 years ]

Secondary Outcome Measures:

Progression free survival [ Time Frame: 5years ]

Other Outcome Measures:

Number of participants with adverse events [ Time Frame: 5years ]


Enrollment:	95
Study Start Date:	February 2008
Study Completion Date:	June 2014
Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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

Locations


Korea, Republic of
Gachon university Gil Medical Center
Incheon, Korea, Republic of

Sponsors and Collaborators

Gachon University Gil Medical Center

More Information


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 10, 2016

Keywords provided by Eun Kyung Cho, Gachon University Gil Medical Center:


Pemetrexed Gefitinib iressa alimta

Additional relevant MeSH terms:


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 Gefitinib Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on August 18, 2017

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