UMIN ID: UMIN000014345
Registered date:23/06/2014
Weekly Paclitaxel in Combination with Bevacizumab in Patients with Non-Squamous Non-Small Cell Lung Cancer Previously Untreated -A 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 previously untreated |
| Date of first enrollment | 2014/06/23 |
| Target sample size | 36 |
| 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 previously untreated |
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)History of hematoemesis, ileus and gastroduodenal ulcer (10)Need for drainage of pleural effusion, acsites or pericardial effusion (11)Medically uncontrolled thromboembolism (12)Symptomatic CNS metastases previously untreated (13)CNS or Psychological disorders (14)Medically uncontrolled hypertension or diabetes mellitus (15)Nonhealing wound and surgery within 4 weeks before treatment (16)History of hemoptysis; one-half teaspoon of bright red blood per event (17)Recent use of aspirin (>=325 mg/day) (18)Severe bone marrow suppression (19)Pregnancy or lactation |
Related Information
| Primary Sponsor | Division of Medical Oncology and Molecular Respirology, Faculty of Medicine, Tottori University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Division of Medical Oncology and Molecular Respirology, Faculty of Medicine, Tottori University |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masahiro Kodani |
| Address | 36-1 Nishi-machi, Yonago, Tottori Japan |
| Telephone | 0859-38-6537 |
| kodani@med.tottori-u.ac.jp | |
| Affiliation | Faculty of Medicine, Tottori University Division of Medical Oncology and Molecular Respirology |
| scientific contact | |
| Name | Eiji Shimizu |
| Address | 36-1 Nishi-machi, Yonago, Tottori Japan |
| Telephone | 0859-38-6537 |
| eiji@med.tottori-u.ac.jp | |
| Affiliation | Faculty of Medicine, Tottori University Division of Medical Oncology and Molecular Respirology |