Unique ID issued by UMIN | UMIN000005991 |
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Receipt number | R000007089 |
Scientific Title | A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer. |
Date of disclosure of the study information | 2011/07/20 |
Last modified on | 2011/07/17 22:41:10 |
A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.
A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.
A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.
A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.
Japan |
Non-squamous non-small cell lung cancer (EGFR mutation status Negative)
Pneumology |
Malignancy
YES
To investigate the efficacy and safety of Pemetrexed plus Carboplat plus Bevacizumab in followed by maintenance Pemetrexed in patients with previously untreated stage III/IV non-squamous non-small-cell and lung cancer.
Safety,Efficacy
Phase II
RR: Response rate
QOL: Quality of life
DCR: Disease control rate
PFS: Progression free Survival
OS: Overall survival
AE: Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Four cycles of Pemetrexed + Carboplatin + Bevacizumab followed by maintenance Pemetrexed until disease progression
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1)Histologically or cytologically confirmed non-squamous non-small cell lung cancer.(EGFR mutation status negative).
2)Stage III/IV unresectable or unsuitable for radical irradiation Non-Squamous NSCLC.
3)No prior chemotherapy .
4)Measurable tumor sites
5)ECOG-PS of 0 or 1.
6)20years-old,more than 80years-old
7)No prior systemic anticancer therapy including palliative brain or bone irradiation within 2 weeks of proposed entry to this trial.
8)Life expectancy more than 3 months.
9)No problem adequate organ function
10) Written informed consent from the patients.
1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan.
2)Patients with active co-morbidities including severe conditions.
1.uncontrollable angina pectoris, myocardial infarction within 3 months, severe heart disease.
2.uncontrollable diabetes, hypertension.
3.severe infection
4.paresis of intestine, illeus
5.Hemoptysis(more than 2.5ml), continuous or treatment-required bloody sputum
6.Great vessel involvement
7.Melena
8.Receiving anticoagulant drug
9.Uncontrolled urinari protein
10.CongenitalbleedingdiathesisCoagulation abnormalities
11.Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
3)Patients with massive pleural and cardiac effusion and ascites that need to be immediately treated.
4) Brain metastases with neurological symptoms.
5) Active double cancer.
6)Pregnancy, breast feeding and suspected pregnancy.
7)History of grave drug allergic reaction.
8) Psychiatric disorder.
9) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor.
35
1st name | |
Middle name | |
Last name | Kazutoshi Isobe |
Toho University Omori Medical Center
respiratory medicine
6-11-1 Omorinishi, Ota-ku, Tokyo, 143-8541, Japan
03-3762-4151
1st name | |
Middle name | |
Last name | Kazutoshi Isobe |
Toho University Omori Medical Center
respiratory medicine
6-11-1 Omorinishi, Ota-ku, Tokyo, 143-8541, Japan
03-3762-4151
kazutoshiisobe@aol.com
Toho University Omori Medical Center
Non
Self funding
NO
2011 | Year | 07 | Month | 20 | Day |
Unpublished
Open public recruiting
2011 | Year | 07 | Month | 01 | Day |
2011 | Year | 08 | Month | 01 | Day |
2011 | Year | 07 | Month | 17 | Day |
2011 | Year | 07 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007089
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