A Phase II study of Paclitaxel plus Carboplatin plus Bevacizumab that introduces concept of Clinical PD in recurrent or advanced non-squamous non-small cell lung cancer.
- Conditions
- recurrent or advanced non-squamous non-small-cell and lung cancer.
- Registration Number
- JPRN-UMIN000005328
- Lead Sponsor
- Dept. of Respiratory Medicine, Osaka University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
Not provided
Patients with at least one of the following conditions are ineligible 1)Have central nervous system metastases 2) Radiological evidence of tumor invading or abutting major blood vessels and evidence of brain metastases, even if previously treated. But eligible for disappeared or controlled brain metastases 3)history of active double cancer within 5 years 4)History of hemoptysis with 2.5mL or more. a) continue hemosputum for more than one week b) have had or require continuous oral administration of hemostat c) have had or require injectable administration of hemostat 5)Have possibly complication related to bleeding episode 6)Great vessel involvement 7)Have received radiation therapy to lesions of lung 8)Currently have or have a history of a cardiac effusion which requires treatment 9)Currently have brain vascular disease with symptom, or have a history of it within one year before enrollment 10)Have a serious concomitant active infection, which needs antibiotics, antimycotic drugs or virucide 11)Operation has been scheduled for the treatment period 12)Receiving anticoagulant drug(including Aspirin over 325mg/day). 13)Perforation of the digestive tract or history of the perforation of the digestive tract within the past one year. 14)Uncontrollable Hypertension or Gastrointestinal ulceration 15)Severe cardiac disease 16)Interstitial pneumonia or pulmonary fibrosis detectable on X ray. 17)Peripheral neuropathy > Grade2 18)Hypersensitivity of Protocol agents or Taxans or alcohol and the medicine made of the polio castor oil content. 19)Cases with past history of administration of Protocol agents 20) Pregnancy, breast feeding and suspected pregnancy 21) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival
- Secondary Outcome Measures
Name Time Method Evaluation of safety Objective response rate Overall Survival