Non-small cell lung cancer
Conditions
Interventions
1)lactferin is administered orally. Level 1 lactoferin 1g/day Level 2 lactoferin 2g/day Level 3 lactoferin 3g/day 2)TS-1 80mg/m2/day is administered orally for 2 consecutive weeks every 3 weeks.
Sponsors
Kanagawa Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)histologically or cytologically confirmed unresectable non-small cell lung cancer, previous 2- regimen chemotherapy 2)Presence of at least one measurable lesion 3)ECOG Performance status 0-2 4)Life expectancy more than 3 months 5)Age: 20-84 years old 6)preserved organ's function Hb>=9g/d WBC>=3,000/mm3 Neutro>=1,500/mm3 Plt>=100,000/mm3 Total serum bilirubin <=1.5 mg/dl GOT/GPT,ALP <=2xULNmg/dl Serum creatinine <=1xULNmg/dl Ccr>=50ml/min 7)Acquisition of written informed consent
Exclusion criteria
Exclusion criteria: 1)pulmonary fibrosis or interstitial pneumonitis evident 2)Massive pleural effusion, pericardial effusion,and abdominal effusion 3)Simultaneous or metachronous double cancers 4)serious complications below a)myocardial infarction within 6 months b)Uncontrolled diabetes or hypertension c)Current severe infection, or suspicious of severe infection d)History of serious drug allergic reaction e)Massive effusion or edema f)Patients whose participation in the trial is judged to be inappropriate by the attending doctor 5)Symptomatic brain metastasis 6)now pregnant or lactation 7)History of radiation therapy or operation for lung cancer within 28 days at the time of entry. 8)History of unapproved drugs within 28 days at the time of entry. 9)Participation in this study before 10)History of serious allergic reaction with S-1 11)Being treated with other pyrimidine fluoride antineoplastic agents. 12)Being treated with flucytosine. 13)Wattery diarrhea 14)lactose intolerance 15)difficult to perform or continue of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RD : Recommended Dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety,Efficacy,Immunological response,QOL | — |
Countries
Japan
Outcome results
None listed