None listed
Conditions
Interventions
Drug : Group A
Pemetrexed pemetrexed 500mg / ? + Carboplatin carboplatin AUC5 every 21 days
Group B
Pemetrexed 500mg / ? every 21 days
After 4 cycles of treatment with each of the above groups, patients should be treated with pemetrexed monotherapy every 21 days (3 weeks), unless the disease progres
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Progressive non-small cell lung cancer (stage IV by AJCC 7 plate), except histologically or cytologically diagnosed squamous cell carcinoma - If there is recurrence after surgery or radiation therapy but there is a measurement lesion and other local treatment is impossible - Patients over 70 years of age -Eastern Cooperative Oncology Group (ECOG) Full Body Performance (0-1) - One or more lesions that can be measured or evaluated according to the RECIST 1.1 standard - Life expectancy is over 3 months - Appropriate bone marrow function: ANC =1.500 / ul, hemoglobin=9.0 g / dL (correctable by transfusion), and platelet =100.000 / ul, Adequate bone marrow function - adequate renal function (Serum creatinine = 1xUNL or calculated cratinine clearnace = 45ml / min - adequate liver function (Serum bilirubin = 1.25 x UNL, AST (SGOT) and ALT (SGPT) = 3 x UNL, alkaline phosphatase = 3 x UNL except bone metabolism with no epilepsy) - Patients who voluntarily participated in this study and agreed to the written agreement
Exclusion criteria
Exclusion criteria: - Previous history of immunotherapy, biological or chemotherapy - Penicillin on cefotaxime or carboflatin - fluid retention (eg, pleural fluid or pericardial fluid) that is refractory to treatment or not clinically controlled - Acute infection requiring antibiotic treatment - Surgery requiring general anesthesia within 4 weeks of clinical trial - Severe cardiovascular disease (ie uncontrolled hypertension, acute myocardial infarction within 6 months, unstable angina, congestive heart failure with NYHA grade 2 or greater, or severe arrhythmia) - Stop pemetrexed doses of long-lived salycylates such as Asprin, nonsteroidal anti-inflammatory drugs (NSAIDs) or Cox-2 inhibitors (including NSAIDs or naproxen, piroxicam, diflunisal, naabumetone, rofecoxib, celecoxib) If you can not - Patients with uncontrolled brain damage. (At least 2 weeks of radiation therapy or at least 1 week of surgery including gamma knife surgery, and steroid treatment at least 2 weeks before radiation therapy) - Peripheral nerve lesion = grade 2 History of radiation therapy within 2 weeks Other malignant diseases, including non-melanoma skin cancer, in situ cervical cancer, and thyroid cancer, which were cured within 5 years - Patients who are pregnant or lactating - If there is serious accompanying disease based on the judgment of other researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) comparison | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of response rate (RR);overall survival (OS);Quality-of-life (QoL);Charlson Comorbidity Index (CCI) | — |
Countries
Korea, Republic of
Contacts
Public ContactSang-We Kim
Asan Medical Center
Outcome results
None listed