Unique ID issued by UMIN | UMIN000002622 |
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Receipt number | R000003194 |
Scientific Title | Pemetrexed Monotherapy for Performance Status 2 Patients in Treatment of Non-Small and Non-Squamous Cell Lung Cancer Patients Without EGFR Mutation. |
Date of disclosure of the study information | 2009/10/15 |
Last modified on | 2014/12/11 15:08:38 |
Pemetrexed Monotherapy for Performance Status 2 Patients in Treatment of Non-Small and Non-Squamous Cell Lung Cancer Patients Without EGFR Mutation.
Pemetrexed Monotherapy for Performance Status 2 Patients
Pemetrexed Monotherapy for Performance Status 2 Patients in Treatment of Non-Small and Non-Squamous Cell Lung Cancer Patients Without EGFR Mutation.
Pemetrexed Monotherapy for Performance Status 2 Patients
Japan |
non-small cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
YES
To evaluate the efficacy and safety of pemetrexed monotherapy for performance status 2 patients in treatment of non-small and non-squamous cell lung cancer patients without EGFR mutation.
Safety,Efficacy
Confirmatory
Phase II
progression free survival
response rate
overall survival
disease control rate
safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Pemetrexed at a dose of 500mg/m2 every 3 weeks is administered until progression disease.
20 | years-old | <= |
Not applicable |
Male and Female
1)Histologically or cytologically proven non-squamous non-small cell lung cancer
(without large cell neuroendocrine carcinoma)
2)Non-squamous non-small cell cancer patients with stage IIIB(with pleural dissemination or malignant pleural effusion),stage IV or recurrent disease after surgery,who have no prior chemoterapy
3)With measurable or inmeasurable lesion
4)If the patient underwent radiotherapy, there should be the following interval between the radiotherapy and the registration
i)Radiotherapy including pulmonary field ->3 months
ii)Radiotherapy other than thoracic radiation ->1 month
5)over 20 years old
6)ECOG PS 2
7)without (or unknown) EGFR mutation
8)Adequate organ function
9)Life expectancy more than 3 months
10)Written informed consent
1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan
2)History of drug induced interstitial pneumonia
3)History of severe drug allergy
4)History of active infection or other serious disease condition
(GI bleeding,etc.)
5)History of poorly controlled pleural effusion,pericardial effusion and ascites
6)History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,herat failure,etc.)
7)Uncontrollable diabetes mellitus
8)History of symptomatic brain metastases
9)Hystory of active double cancer
10)History of active psychological disease
11)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
35
1st name | |
Middle name | |
Last name | Nobuyuki Katakami |
Institute of Biomedical Research and Innovation
Integrated Oncology
2-2, Minatojimaminamimachi, Chuoku, Kobe
078-304-5200
1st name | |
Middle name | |
Last name | Akito Hata |
Institute of Biomedical Research and Innovation
Integrated Oncology
2-2, Minatojimaminamimachi, Chuoku, Kobe
078-304-5200
a-hata@fbri.org
Kobe Lung Cancer Oncology Study Group (KLOG)
None
Self funding
NO
神戸市立医療センター中央市民病院 呼吸器内科
神戸大学医学部附属病院 呼吸器内科
先端医療センター 総合腫瘍科
兵庫県立がんセンター 呼吸器内科
倉敷中央病院 呼吸器内科
桂病院 呼吸器内科
2009 | Year | 10 | Month | 15 | Day |
Unpublished
Terminated
2009 | Year | 08 | Month | 10 | Day |
2009 | Year | 09 | Month | 01 | Day |
2013 | Year | 08 | Month | 31 | Day |
2013 | Year | 08 | Month | 31 | Day |
2014 | Year | 08 | Month | 31 | Day |
2014 | Year | 08 | Month | 31 | Day |
2009 | Year | 10 | Month | 12 | Day |
2014 | Year | 12 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003194
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