Non-Small, Non-Squamous Cell Lung Cancer
Conditions
Interventions
combined chemotherapy with carboplatin plus pemetrexed
Sponsors
Kochi University, School of Medicine, Department of Hematology and Resporatory Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically proven non-small, non-squamous cell carcinoma. 2) Stage IIIb /IV patients with no prior chemotherapy and relapsed patients who previously received surgery. Relapsed patients after surgery who previously received only oral anti-tumor drug (excluding epidermal growth factor receptor tyrosine kinase inhibitor) as post operative adjuvant therapy. Palliative radiotherapy against tumors, which are not measurable lesions, is acceptable. 3) Patients aged 70 years or older. 4) Performance status (ECOG) 0-1 5) Sufficient function of main organ and bone marrow filled the following criteria: Leukocyte counts, 3,000/mm3 or over. Neutrophil counts, 1,500/mm3 or over. Platelets, 100,000/mm3 or over. Hemoglobin, 9.0 g/dl or over. AST and ALT, x 2 of upper limit of normal (ULN) or less. Total bilirubin, 1.5mg/dl or less. Serum creatinin, x 1.5 of ULN or less. No serious arrhythmia. PaO2 60 Torr or above, or SpO2 90% or above. No evident interstitial pneumonia 6) Patients who has at least one or more measurable lesion(s) by RECIST. 7) Patients who are considered to survive for more than 3 months. 8) Patients providing written informed consent.
Exclusion criteria
Exclusion criteria: 1) Squamous cell carcinoma 2) Cases with previous radiation therapy against primary tumor 3) Patients with superior vena cava (SVC) syndrome 4) Patients with severe drug allergy 5) Patients with massive and/or uncontrollable pleural effusion 6) Patients with massive ascites, or pericardial effusion 7) Patients with active severe infections 8) Patients with active lung disease such as interstitial pneumonia or lung fibrosis 9) Patients with symptomatic brain metastasis 10) Patients with active concomitant malignancy 11) Patients with uncontrollable complications such as psychiatric problems 12) Inappropriate patients for this study judged by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate, progression free survival, 1 year survival, safety, quality of life | — |
Countries
Japan
Contacts
Public ContactTetsuya Kubota
Kochi University, School of Medicine Department of Hematology and Respiratory Medicine
Outcome results
None listed