Unique ID issued by UMIN | UMIN000004573 |
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Receipt number | R000005455 |
Scientific Title | Phase II trial of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer |
Date of disclosure of the study information | 2010/11/17 |
Last modified on | 2014/04/24 11:56:31 |
Phase II trial of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer
Phase II trial of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer
Phase II trial of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer
Phase II trial of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer
Japan |
Non-small-cell lung cancer
Pneumology |
Malignancy
NO
Evaluation of the efficacy of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer
Efficacy
Exploratory
Explanatory
Phase II
Three-months progression free rate
Overall response rate
Overall survival
Toxicity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Paclitaxel at a dose of 200mg/m2 and bevacizumab 15mg/kg were administrated every 21 days until disease progression, unacceptable toxicity, patient refusal, alternate treatment, or investigator's decision to remove patient from study.
20 | years-old | <= |
75 | years-old | > |
Male and Female
1) Non-squamous non-small-cell lung cancer with histologic or cytologic evidence.
2) Clinical stage IV
3) Previously treated with more than one systemic chemotherapy
4) Age >=20, <75
5) ECOG performance status <=2
6) Adequate organ functions like below
WBC >=3000/mm3
Neutrophil count >=1500/mm3
Platelet count >=100000/mm3
Serum creatinine <=1.2mg/dl
Total bilirubin <=1.5mg/dl
AST <=80IU/l
ALT <=80IU/l
PaO2 >=60Torr or SpO2 >90%
7) Written informed consent
1) Previously treated with paclitaxel and / or bevacizumab
2) Patients with brain metastasis
3) Patients with hemoptysis
4) Patients receiving therapeutic anticoagulation
5) Patients with complications like below
Active infection
Acute myocardial infarction during recent 6 months or the other severe heart disease
Uncontrollable diabetes mellitus
Uncontrollable hypertension
Active psychological disease
6) Hypersensitivity to paclitaxel and / or bevacizumab
7) Active concomitant malignancy
8) Pregnancy or lactation
9) Inappropriate patients for this study judged by the physicians
42
1st name | |
Middle name | |
Last name | Shintaro Kanda |
Shinshu University School of Medicine
First Department of Internal Medicine
3-1-1 Asahi, Matsumoto, Nagano 390-8621 Japan
0263-37-3631
shintarokanda@gmail.com
1st name | |
Middle name | |
Last name | Shintaro Kanda |
Shinshu University School of Medicine
First Department of Internal Medicine
3-1-1 Asahi, Matsumoto, Nagano 390-8621 Japan
0263-37-3631
shintarokanda@gmail.com
First Department of Internal Medicine, Shinshu University School of Medicine
First Department of Internal Medicine, Shinshu University School of Medicine
Self funding
NO
2010 | Year | 11 | Month | 17 | Day |
Unpublished
Terminated
2010 | Year | 11 | Month | 16 | Day |
2010 | Year | 12 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2010 | Year | 11 | Month | 16 | Day |
2014 | Year | 04 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005455
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