Chemo-na&
Conditions
Interventions
cisplatin (75mg/m2) + pemetrexed (500mg/m2) level 1: crizotinib 200mg twice daily day1-7 level 2: crizotinib 250mg twice daily day1-7 level 3: criztotinib 250mg twice daily
Sponsors
National organization Kinki-chuo chest medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirned non-small-cell lung cancer (NSCLC) 2)Diagnosed EML4-ALK positive by Fish or PCR 3)With measurable lesion 4)Stage IIIB without any indications for radiotherapy or Stage IV or recurrent disease after surgery or radiotherapy who have no prior chemoterapy 5)20 years old or older 6)ECOG PS 0-1 or older 7)Adequate organ function 8)Life expectancy more than 3 months 9)Signed informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated schedule of crizotinib with cisplatin and pemetrexed | — |
Countries
Japan
Contacts
Public ContactKazuhiro Asami
National organization Kinki-chuo chest medical center medical oncology
Outcome results
None listed