A phase 1 study of cisplatin/pemetrexed/crizotinib followed by maintenance crizotinib in patients with stage 3B or 4 EML4-ALK positive non-small-cell lung cancer.
- Conditions
- Chemo-na&iumlve advanced ALK positive NSCLC
- Registration Number
- JPRN-UMIN000009256
- Lead Sponsor
- ational organization Kinki-chuo chest medical center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Not provided
1)Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray 2) History of poorly controlled pleural effusion,pericardial effusion and ascites 3)Not appropriate to receive the folic acid and vitamin B12 formulation 4)SVC syndrome 5)Symptomatic brain metastases 6)History of active double cancer 7)Uncontrollable diabetes mellitus and hypertension 8)Diagnosed as liver cirrhosis by image findings or clinical laboratory 9)Suffers from an infectious disease to need antibiotic treatment 10)History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,herat failure,etc within 6 months) 11)Pregnant female or sexually active males/females unwilling to use contraception during the protocol treatment 12)History of grave drug allergic reaction 13)Acute inflammatory disease 14)An agreement is not obtained for support therapy such as transfusion etc. 15)History of active psychological disease 16)Having the bleeding tendency which is clear in clinic 17)Taking continuous whole body administration (oral administration or intravenous administration) of steroid 18)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum Tolerated schedule of crizotinib with cisplatin and pemetrexed
- Secondary Outcome Measures
Name Time Method