advanced/recurrent non-small cell lung cancer (NSCLC)
Conditions
Interventions
1000mg/m2 of Gemcitabine plus AUC 3 of carboplatin were administered every two weeks and was continued until disease progression
Sponsors
Clinical Research Support Center Kyushu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with histologically proven non-small cell lung cancer (2) Patients with measurable disease (3) Chemotherapy in patients with unreliable Stage IIIb and Stage IV or in patients with postoperative relapse Untreated patients (4) Patients with a clinical signs Performance Status of 0 to 1 (5) Patients aged 70 years or older at enrollment (6) Patients who have not received prior chemotherapy, radiation therapy, or immunotherapy (BRM) (7) Major organ functions (bone marrow, liver, kidney, etc.) are well preserved, and the following criteria are used Patients who meet WBC count: 4,000 per mm3 and 12,000 per mm3 Neutrophils: 2,000 per mm3 or more Platelets count: 100,000 per mm3 or more Haemoglobin: 9.0 g/dl or more GOT and GPTs: less than 2.5 times the normal values of the institution Total bilirubin: not more than 2.0 mg/dl Serum creatinine: not more than 1.2 mg/dl PaO2 :>= 60 Torr (8) Patients who are expected to survive for more than 3 months (9) Patients with written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: (1) Patients with obvious infections (2) Patients with fever (38C or higher) (3) Serious complications (heart disease, pulmonary fibrosis/interstitial pneumonia, bleeding tendency, uncontrolled) Patients with hypertension, diabetes mellitus, etc. (4) Patients with active double cancer (disease-free interval <5 years) (5) Symptomatic patients with brain metastases (6) Patients with pleural effusions and ascites requiring treatment (7) Patients with pericardial effusion (8) Patients with varicella (9) Patients with motor paralysis or peripheral nerve symptoms (excluding those originating from the primary disease) (10) Patients with a history of drug hypersensitivity (11) Pregnant, breastfeeding, and women of childbearing potential (willingness) (12) Other patients judged inappropriate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rresponse rate (RR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) Overall survival (OS) Safety | — |
Countries
Japan
Contacts
Public ContactJunji Uchino
Kyoto Prefectural University of Medicine Department of Pulmonary Medicine
Outcome results
None listed