A randomized phase II trial of docetaxelor pemetrexed with or without gefitinib in elderly advanced non-small cell lung cancer patients harboring activating EGFR mutation after failure of the therapy as first-line treatment.
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-UMIN000007765
- Lead Sponsor
- The Japan-Multinational Trial Organization(JMTO)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Not provided
1.Patients including clients and employee or stuff of the participating medical institution who are involved in planning and conducting this study 2.Patients who relapsed in one year from the last day of adjuvant chemotherapy 3.Active infection (fever of 38.0 degrees centigrade or higher) 4.Patients with past history including acute interstitial pneumonia, pulmonary drug toxicity and radiation pneumonitis treated with corticosteroids 5.Interstitial pneumonia/ Pulmonary fibrosis 6.Patietns with ileus 7.Uncontrollable diarrhea 8.Active double cancer 9.Serious allergy history 10.Patients with refractory gastric ulcer or a duodenal ulcer 11.Uncontrollable massive,pleural effusion or cardiac effusion 12.Systemic administartion of corticosteroids 13.History of docetaxe or pemetrexed therapy 14.serious medical complications (uncontrollable pulmonary disease, heart disease, kidney disease, liver disease) and inappropriate patients for this study judged by the physicians physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Response Rate Disease Control Rate Overall survival Safety