Feasibility study of carboplatin, paclitaxel and bevacizumab in advanced non-squamous non-small-cell lung cancer with idiopathic interstitial pneumonias
- Conditions
- Advanced non-squamous non-small-cell lung cancer with idiopathic interstitial pneumonias
- Registration Number
- JPRN-UMIN000008189
- Lead Sponsor
- The Ministry of Health, Labour and Welfare of Japan awarded to the Study Group on Diffuse Pulmonary Disorders, Scientific Research/Research on intractable diseases
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 27
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety (frequency of acute exacerbation of interstitial pneumonias)
- Secondary Outcome Measures
Name Time Method progression-free survival, overall survival, response rate, time to response, frequency of of acute exacerbation of interstitial pneumonias by CTCAE v4.03 grades