Unique ID issued by UMIN | UMIN000005228 |
---|---|
Receipt number | R000006187 |
Scientific Title | Phase II study of bevacizumab and irinotecan as second-line therapy in patients with metastatic colorectal cancer previously treated with fluoropyrimidine, oxaliplatin, and bevacizumab |
Date of disclosure of the study information | 2011/03/09 |
Last modified on | 2016/03/09 11:19:56 |
Phase II study of bevacizumab and irinotecan as second-line therapy in patients with metastatic colorectal cancer previously treated with fluoropyrimidine, oxaliplatin, and bevacizumab
Bevacizumab and irinotecan as second-line therapy in patients with metastatic colorectal cancer
Phase II study of bevacizumab and irinotecan as second-line therapy in patients with metastatic colorectal cancer previously treated with fluoropyrimidine, oxaliplatin, and bevacizumab
Bevacizumab and irinotecan as second-line therapy in patients with metastatic colorectal cancer
Japan |
metastatic colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the effectiveness and safety of bevacizumab and irinotecan as second-line therapy in patients with metastatic colorectal cancer previously treated with fluoropyromidine, oxaliplatin, and bevacizumab
Safety,Efficacy
Confirmatory
Explanatory
Phase II
Progression Free Survival
Response Rate
Overall survival
Frequency of adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Active
1
Treatment
Medicine |
1) Bevacizumab 10mg/kg is administered by 10-30min. intravenous infusion, followed by irinotecan 150mg/m2 by 90 min infusion
(2)Patients should be received this chemotherapy biweekly until disease progression
20 | years-old | <= |
Not applicable |
Male and Female
1) Written informed consent
2) Age: 20 years old or older
3) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
4) Histological confirmation of colorectal cancer
5) Life expectancy greater than or equal to 3 months
6)unresectable primary tumor or with one or more unresectable metastatic tumor
7)Measurable or evaluable disease (measurable lesions in RECIST ver1.1 criteria is unnecessary)
8)Progression during or after first line chemotherapy for metastatic disease, including Oxaliplatin based chemotherapy with bevacizumab(over 4 courses)
9)Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery >=4 weeks. Radiation therapy >= 4weeks
10)Vital organ functions (listed below) are preserved within 2 weeks prior to entry
i) white blood >= 3000/mm3
ii) Neutrophils >= 1500/mm3
iii) Platelets >= 80000/mm3
iv) Hemoglobin >= 8.0 g/dl
v) Total bilirubin <= upper limit of normal (ULN) X 1.5
vi) AST and ALT <= ULMX2.5 (5XULM allowed in case of liver metastases)
vii) Serum creatinine <= ULM X 1.5mg/dl
viii) Protein urea <= 1+
1)Radiological evidence of CNS metastases or brain cancer
2)Complication of cerebrovascular disease or symptoms within 1 year
3) complication of GI perforation, or past history of perforation within 1 year
4) Uncontroled Gastrointestinal Ulcer
5) Uncontrolled Diarrhea
6) Receiving Atazanavir Sulfate
7)Paralytic or mechanical bowel obstruction
8) Evidence of bleeding diathesis or coagulopathy.
9) Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS)
10) Clinically significant (i.e. active, CTCAEv4.0 >=Grade2) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction
11) Uncontrolled Hypertension
12) Need to drain malignant coelomic fluid.
13) Evidence of interstinal lung disease, or pulmonary fibrosi
14) Uncontrolled infection
15) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers
16) History of the serious hypersensitivity for Fluorouracil or bevacizumab
17) Treatment history of irinotecan
18) Other conditions not suitable for this study
33
1st name | |
Middle name | |
Last name | Kazuhiko Hayashi |
Tokyo Women's Medical University
Department of chemotherapy and palliative care
8-1, Kawadacho, Shinjukuku, Tokyo, Japan
03-3353-8111
kuramochi@chemo.jp
1st name | |
Middle name | |
Last name | Hidekazu Kuramochi |
Tokyo Women's Medical University
Department of chemotherapy and palliative care
8-1, Kawadacho, Shinjukuku, Tokyo
03-3353-8111
kuramochi@chemo.jp
Tokyo Women's Medical University
None
Self funding
NO
2011 | Year | 03 | Month | 09 | Day |
Unpublished
Completed
2011 | Year | 03 | Month | 06 | Day |
2011 | Year | 03 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2015 | Year | 11 | Month | 01 | Day |
2016 | Year | 03 | Month | 01 | Day |
2011 | Year | 03 | Month | 09 | Day |
2016 | Year | 03 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006187