advanced squamous cell lung carcinoma
Conditions
Interventions
Patients receive nedaplatin(80-100 mg/m2, day1) plus S-1(80-120 mg/day, day1-14) every 3 weeks.
Sponsors
Keio University School of Medicine, division of Pulmonary Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Sufficient oral intake 2.Histologically or cytologically confirmed squamous cell or adenosquamous cell lung cancer. Stage III without any indications for radiotherapy or Stage IV. 3.Age: 20 years to less than 80 years. 4.Patients with no previous treatment ( chemotherapy or radiotherapy) for lung cancer. Incrude recurrent disease after surgery who have no prior chemoterapy. 5.Measurable by RECST(ver 1.1) criteria. 6.adequate bone marrow, liver, and renal functions Hb > 9.0 g/dL-1 WBC > 3500-12,000 mm-3 neutro > 2,000 mm-3 Plt > 100,000 mm-3 T-Bil< 1.5x upper normal limit AST(GOT), ALT(GPT)< 1.5x upper normal limit creatinine clearance > 60 ml/min Pao2 > 60mmHg or SpO2 > 90% 7.ECOG performance status of 0 or 1 8.a life expectancy of 12 weeks or more 9.Written informed consent
Exclusion criteria
Exclusion criteria: 1.History of grave drug allergic reaction 2.Patients under treatment with phenytoin or flucytosine. 3.Serious complications (e.g. intestinal paralysis, intestinal obstruction, interstitial pneumonia or fibroid lung detectable on chest X-ray films , poorly controlled diabetes, heart failure, renal failure, hepatic failure, or haemorrhagic peptic ulcer etc.). Serious medical complications 4. History of poorly controlled pleural effusion,pericardial effusion and ascites . 5.Symptomatic brain metastasis 6.Patients with uncontrolled water diarrhea or chronic constipation. 7.Active double cancer. Carcinoma in situ and lesions of intramucosal carcinoma will not be included in active double cancer and will be permitted for registration. 8.Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. 9.Males that are currently attempting to produce a pregnancy. 10.Inadequate physical condition, as diagnosed by primary physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I : DLT (Dose-Limiting Toxicity) Phase II : RR (Response Rate) | — |
Countries
Japan
Contacts
Public ContactKatsuhiko Naoki
Keio University School of Medicine Division of Pulmonary Medicine
Outcome results
None listed