platinum pretreated patients with non small cell lung cancer
Conditions
Interventions
pemetrexed 500mg/mm over a 10 minutes intravaenous infusion and carboplatin at an AUC 5mg/mL/min over a 30 minutes intravenous infusion on Day1 of a 21 day cycle.
Sponsors
Osaka Prefectural Medical Center for Respiratory and Allergic deseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed non-small-cell lung cancer with Chemo-naive patients (Radiothrapy to any place other than primary and evaluable lesion is competent) 2) Stage III/IV of platinum pretreated patients 3) Patients aged 20 years or older 4) Karnofsky performance status 0-1 5) Patients who have measurable lesion (In 10mm Slice CT more than 20mm, in 5mm Slice CT more than 10mm) or evaluable lesion by RECIST 6) Adequate organ function 7) Excepted to live over 3 months after administration day 8) Written informed consent from the patients
Exclusion criteria
Exclusion criteria: Exclusion criterias are as follows 1: Active interstitial pneumonia identified by chest X-ray 2: Uncontrolled massive pleural effusion or cardiac effusion 3: Superior vena cava syndrome 4: Uncontrolled brain metastases 5: Uncontrolled diabetes mellitus, hypertension, hepatic disorder, angina pectoris or previous myocardial infarction within the last 12 months 6: Severe infection 7: Pregnancy or lactation 8: Active concomitant malignancy 9: History of severe allergic reactions to drugs 11: Severe and unstable medical 10morbidities 11: Judgment to attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| safety,OS,PFS | — |
Countries
Japan
Contacts
Public ContactMotohiro Tamiya
Osaka Prefectural Medical Center for Respiratory and Allergic deseases Thoracic Malignancy
Outcome results
None listed