Unique ID issued by UMIN | UMIN000005179 |
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Receipt number | R000006152 |
Scientific Title | Phase ll study of Panitumumab for advanced colorectal cancer which has prior therapy of Bevacizumab |
Date of disclosure of the study information | 2011/03/03 |
Last modified on | 2016/03/04 10:50:29 |
Phase ll study of Panitumumab for advanced colorectal cancer which has prior therapy of Bevacizumab
Phase ll study of Panitumumab for advanced colorectal cancer which has prior therapy of Bevacizumab
Phase ll study of Panitumumab for advanced colorectal cancer which has prior therapy of Bevacizumab
Phase ll study of Panitumumab for advanced colorectal cancer which has prior therapy of Bevacizumab
Japan |
metastatic colorectal cancer
Surgery in general | Gastrointestinal surgery |
Malignancy
NO
Bevacizumab for advanced colorectal cancer refractory to initial chemotherapy was used, Panitumumab to verify the effectiveness of combination therapy as a secondary treatment.
Safety,Efficacy
Phase II
Response Rate:RR
Safety
Overall survival :OS
Progression free survival :PFS
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
FOLFOX+Panitumumab repeat every 14 days until discontinuance criteria.
FOLFIRI+Panitumumab repeat every 14 days until discontinuance criteria.
20 | years-old | <= |
Not applicable |
Male and Female
1) Colorectal cancer histlogical proven
2) Unresectable
3) KRAS wild type
4) Prior treatment was L-OHP-based or CPT-11 based chemotherapy
5) No prior panitumumab/cetuximab
6) More than 20 years old
Expect to survive more than 3 months
ECOG performance status: 0-2
7) Organs (bone marrow, lung, liver, and kidney) failure is not advanced.
i) Neutrophil count: more than 1,500 / mm3
ii)Platelet: more than 100,000 / mm3
iii)Hemoglobin: more than 8.0g/dl
iv)Serum total bilirubin : less than 2.0 mg / dl
v)Serum creatinine : less than 1.5 mg / dl
8) ECG no abnormalities in 28 days before
9) Lesion measured by RECIST in
10) Written patient consent was obtained from patients.
1) Advanced pleural effusion, ascites
2) CNS metastases
3) Infection
4) Diarrhea (watery stool)
5) Heart disease as a clinical problem
6) Severe complications (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, it is difficult to control diabetes, heart failure, kidney failure, liver failure etc.)
7) Active double cancer
8) Severe mental disorder
9) Irinotecan, oxaliplatin, panitumumab history of hypersensitivity to
10) Treatment with atazanavir sulfate
11) Pregnant and lacting women
12) Severe drug allergy
13) Judged unfit to by doctors in this study
20
1st name | |
Middle name | |
Last name | Yasushi Rino |
Yokohama city university
Department of surgery
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
045-787-2645
rino@med.yokohama-cu.ac.jp
1st name | |
Middle name | |
Last name | Norio Yukawa |
Yokohama city university
Department of surgery
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
045-787-2645
nryukawa@yokohama-cu.ac.jp
Yokohama city university
None
Self funding
NO
2011 | Year | 03 | Month | 03 | Day |
Unpublished
Terminated
2011 | Year | 01 | Month | 07 | Day |
2011 | Year | 02 | Month | 01 | Day |
2015 | Year | 01 | Month | 01 | Day |
2015 | Year | 01 | Month | 01 | Day |
2015 | Year | 01 | Month | 01 | Day |
2015 | Year | 01 | Month | 01 | Day |
2011 | Year | 03 | Month | 03 | Day |
2016 | Year | 03 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006152
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