A Phase II Study of Pemetrexed and Gefitinib in Chemotherapy Naive Patients with Non-Small Cell Lung Cancer Harboring Mutations of EGFR
Phase 2
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-UMIN000003808
- Lead Sponsor
- Osaka Lung Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
Not provided
Exclusion Criteria
1) Using NSAIDs regularly. 2) Interstitial pneumonia/lung fibrosis on chest CT. 3) Previous drug allergy 4) History of poorly controlled pleural effusion, pericardial effusion and ascites. 5) Active infection. 6) Current Diarrhea. 7) Ileus or intestinal tract paralysis. 8) Symptomatic brain metastasis. 9) Active concomitant malignancy. 10) History of sever heart disease. 11) History of sever psychological disease. 12) Hoped to be pregnant/nursing. 13) Those judged to be not suitable by the attending physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method RR:response rate
- Secondary Outcome Measures
Name Time Method PFS: progression free survival OS: overall survival DCR: disease control rate AEs: adverse events