UMIN ID: UMIN000005608
Registered date:23/05/2011
Weekly Paclitaxel in Combination with Bevacizumab in Patients with Non-Squamous Non-Small Cell Lung Cancer Who Have Failed Previous Treatments-Phase II study-
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Patients with non-squamous non-small cell lung cancer who have failed previous treatments |
| Date of first enrollment | 2011/09/01 |
| Target sample size | 31 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Weekly Paclitaxel in combination with Bevacizumab in patients with non-squamous non-small cell lung cancer who have failed previous treatments |
Outcome(s)
| Primary Outcome | Progression free survival |
|---|---|
| Secondary Outcome | Safety, Disease control rate, Overall response rate, Time to treatment failure, Overall survival |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1)Received transfusion or G-CSF within 14 days prior to enrollment (2)Urine protein>=2+ (3)History of drug allergy (4)Active multiple cancers (5)Severe infection (6)High fever (7)Abnormal cardiac function (8)Severe pulmonary disease; Interstitial pneumonia, severe COPD, pulmonary thromboembolism (9)Need for drainage of pleural effusion, acsites or pericardial effusion (10)History of hematoemesis, ileus and gastroduodenal ulcer (11)symptomatic CNS metastases (12)CNS or Psychological disorders (13)Medically uncontrolled hypertension or diabetes mellitus (14)Nonhealing wound and surgery within 4 weeks before treatment (15)History of hemoptysis; one-half teaspoon of bright red blood per event (16)Therapeutic anticoagulation(full-dose therapeutic anticoagulation current and recent use of aspirin (>=325 mg/day) (17)severe bone marrow suppression (18)Pregnancy or lactation |
Related Information
| Primary Sponsor | Division of Medical Oncology and Molecular Respirology Department of Multidisciplinary Internal Medicine Faculty of Medicine, Tottori University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Division of Medical Oncology and Molecular Respirology Department of Multidisciplinary Internal Medicine Faculty of Medicine, Tottori University |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masahiro Kodani |
| Address | 36-1 Nishi-machi, Yonago-shi, Tottori-ken Japan |
| Telephone | 0859-38-6537 |
| kodani@med.tottori-u.ac.jp | |
| Affiliation | Faculty of Medicine, Tottori University Division of Medical Oncology |
| scientific contact | |
| Name | Eiji Shimizu |
| Address | 36-1 Nishi-machi, Yonago-shi, Tottori-ken 683-0805 Japan |
| Telephone | 0859-38-6537 |
| eiji@med.tottori-u.ac.jp | |
| Affiliation | Faculty of Medicine, Tottori University Division of Medical Oncology |