Advanced non-squamous non-small-cell lung cancer with idiopathic interstitial pneumonias
Conditions
Interventions
chemotherapy(carboplatin, paclitaxel and bevacizumab)
Sponsors
The Ministry of Health, Labour and Welfare of Japan awarded to the Study Group on Diffuse Pulmonary Disorders, Scientific Research/Research on intractable diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Pathologically confirmed non-squamous non-small-cell lung cancer 2.Clinical stage IIIB, IV or post-operative recurrence 3.Chemotherapy naive patients (permit using picibanil for pleurodesis) 4.Stable idiopathic interstitial pneumonia confirmed by high resolution chest CT(taking predonine less than 0.25mg/kg/day or 10mg/day can be allowed) 5.ECOG Performance status 0-1 6.Age over 20 -74 years. 7.Adequate organ function 8.Radiation therapy within 14 days prior to enrollment, major surgery within 28 days prior to enrollment, minor surgery within 7 days prior to enrollment, blood transfusion or administration of hematopoietic factor within 14 days prior to enrollment. 9. Life expectancy > 3 months 10. Signed informed consent
Exclusion criteria
Exclusion criteria: 1.Acute or subacute idiopathic interstitial pneumonia 2.Being suspected or experienced acute exacerbation of idiopathic interstitial pneumonia. 3.Receiving immunosuppressants except for predonine 4.Having collagen diseases 5.Having central nervous system (CNS) metastases 6.History of gross hemoptysis (2.5ml or more) or severe hemosputum (reciving hemostatic drug) 7.Evidence of tumor invading large vessel, trachea or main bronchus on imaging 8.Patients who have received a radiation therapy in chest 9.Having an uncontrolled infection 10.Having a fever (more than 38 degrees (Celsius)) 11.Having severe complications 12.Having massive ascites, pleural effusion or pericardial effusion 13.Active concomitant malignancy without evidence of recurrence within 5 years 14.Having severe drug allegy 15.Evidence of gastrointestinal bleeding, intestinal obstruction and gastrointestinal ulceration 16.History or evidence of uncontrollable gastrointestinal ulceration or gastrointestinal perforation (within 1 year) 17.Having a tendency to bleed. Receiving anticoagulant drug (except Aspirin under 324mg/day). 18.Having a schedule of operations 19.Pulmonary tumor with the cavity (more than 1cm) 20.History of pregnancy or lactation, 21.History of myocardial infarction or cerebral infarction (within 1 year) 22.Haiving hypersensitivity to carboplatin, paclitaxel and bevacizumab, Cremophor E or alchol. 23.Using a home oxygen therapy 24.Decision of ineligibility by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety (frequency of acute exacerbation of interstitial pneumonias) | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, overall survival, response rate, time to response, frequency of of acute exacerbation of interstitial pneumonias by CTCAE v4.03 grades | — |
Countries
Japan
Contacts
Public ContactYuji Minegishi
Nippon Medical School, Division of Pulmonary Medicine, Infectious Disease, and Oncology, Department of Internal Medicine
Outcome results
None listed