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:
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: August 19, 2013
Last verified: August 2013
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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 |
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
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 Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Gefitinib |
Pemetrexed Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Kinase Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015