Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients
This study has been completed.
Sponsor:
Gachon University Gil Medical Center
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
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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 |
| 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
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 ]
| 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) |
| 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
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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
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 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by 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 September 29, 2016