advanced non-small cell lung cancer (NSCLC)
Conditions
Interventions
A group: Biweekly treatment TXL 135mg/m2 day1, 15+CBDCA(AUC=3)day1, 15 every 28 days for 4 cycles
B group: Weekly treatment TXL 90mg/m2 day1, 8, 15 + CBDCA(AUC=6) day1 every 28 days for 4 cycles
Sponsors
Clinical Research Support Center Kyushu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cases of non-small cell lung cancer confirmed by cytology or histology Stage IIIB (radiotherapy-naive cases) and Stage IV (postoperative distant metastases are treated as Stage IV) Cases without prior chemotherapy for this disease Age 20 to 80 years PS(ECOG) 0-1 Cases with measurable lesions according to RECIST criteria Cases with adequate major organ function 1) WBC count > 4,000 per mm3 Or more than 2000 neutrophils per mm3 2) Platelets count > 10000 per mm3 3) Hemoglobin > 9.0/dL 4) GOTs, not more than 2 times the upper limit of normal at GPT institution (However, abnormal values due to liver metastasis are not more than 3 times the upper limit of normal.) 5) Serum total bilirubin < 1.5 mg/dL 6) Upper limit of normal for serum creatinine 1.5-fold or less 7) Electrocardiogram normal (patients without serious heart disease or arrhythmia) 8) PaO2 60 torr or higher (or SpO2 90% or higher) Patients with an expected survival of at least 3 months Written informed consent has been obtained from the patient regarding participation in the study
Exclusion criteria
Exclusion criteria: Cases with serious complications (e.g., severe heart disease or cerebrovascular disorders, difficult-to-control diabetes or hypertension, Severe infection, pulmonary fibrosis, interstitial pneumonia, respiratory failure, hemorrhage, massive pleural effusion, or ascites, Retention, active peptic ulcers, and serious neurologic disease) Cases with symptomatic brain metastases Cases with active double cancers Patients with a history of serious drug hypersensitivity Polyoxyethylene castor oil-containing preparation (cyclosporine preparation) Patients who have experienced hypersensitivity related to a history of administration of a sclerosed castor oil-containing preparation (e.g., an injectable vitamin preparation) Cases with a history of alcohol hypersensitivity Pregnant, lactating and possibly pregnant women Patients with psychosis or psychiatric symptoms who are considered difficult to participate in the study Patients receiving continuous systemic (oral or intravenous) corticosteroids Other cases considered inappropriate by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Progression Free Survival, Overall Survival | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactJunji Uchino
Kyoto Prefectural University of Medicine Department of Pulmonary Medicine
Outcome results
None listed