Unique ID issued by UMIN | UMIN000005184 |
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Receipt number | R000006155 |
Scientific Title | Clinical efficacy and biomarker assessment of Capecitabine plus oxaliplatin (XELOX) in combination with Bevacizumab as second-line therapy in patients with advanced or recurrent colorectal cancer after failure to irinotecan. Multi-center phase II Study. |
Date of disclosure of the study information | 2011/03/03 |
Last modified on | 2019/09/17 17:42:53 |
Clinical efficacy and biomarker assessment of Capecitabine plus oxaliplatin (XELOX) in combination with Bevacizumab as second-line therapy in patients with advanced or recurrent colorectal cancer after failure to irinotecan. Multi-center phase II Study.
Clinical efficacy and biomarker assessment of Capecitabine plus oxaliplatin (XELOX) in combination with Bevacizumab as second-line therapy in patients with advanced or recurrent colorectal cancer after failure to irinotecan.
Clinical efficacy and biomarker assessment of Capecitabine plus oxaliplatin (XELOX) in combination with Bevacizumab as second-line therapy in patients with advanced or recurrent colorectal cancer after failure to irinotecan. Multi-center phase II Study.
Clinical efficacy and biomarker assessment of Capecitabine plus oxaliplatin (XELOX) in combination with Bevacizumab as second-line therapy in patients with advanced or recurrent colorectal cancer after failure to irinotecan.
Japan |
Patients with advanced or recurrent colorectal cancer after failure to irinotecan.
Gastrointestinal surgery |
Malignancy
NO
To assess efficacy and safety of the combination of XELOX+Bevacizumab as second-line therapy in patients with advanced or recurrent colorectal cancer after failure to irinotecan. Furthermore, this exploratory study is also designed to evaluate predictable several growth factor levels in the resected tumor tissues and plasma for this regimen.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
6-month Progression free survival rate
Response rate
Disease control rate
Progression free survival
Overall survival
Time to treatment failure
Safety
Exploring several predictable biomarkers
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Capecitabine plus oxaliplatin (XELOX) in combination with Bevacizumab.
Capecitabine:2000mg/m2/day p.o.(day1-15)
Oxaliplatin:130mg/m2 i.v.(day1)
Bevacizumab:7.5mg/kg i.v.(day1)
to be repeated every 3 weeks
20 | years-old | <= |
Not applicable |
Male and Female
(1) Histological confirmation of colorectal cancer.
(2) Unresectable primary tumor or with one or more unresectable metastatic tumor.
(3) 20 years old or more when received informed consent.
(4) Eastern Cooperative Oncology Group (ECOG) performance status (PS):0 - 2.
(5) With estimative lesion observed in imaging or intraoperation within 28 days before registration. (measurable lesions in RECIST criteria (ver.1.1)is despensable)
(6) Withdrawal from first-line chemotherapy due to toxicity or progressive disease
(7)Patients with metastatic colorectal cancer who had previously received first-line therapy with an irinotecan-based regimen.
(8) No previous treatment with Oxaliplatin contained regimen.
(9) Life expectancy estimated 2 months, and more.
(10) Vital organ functions (listed below) are preserved within 14 days prior to entry.
1. White blood cell count 3500/mm3>= (Neutrophils>=1500/mm3)
2. Platelets>=100,000/mm3
3. Total bilirubin>=upper limit of normal (ULN)*1.5
4. AST and ALT<=upper limit of normal (ULN)*2.5
(<=ULN*5 in case of liver metastasis)
5. Hemoglobin>=9.0g/dl
6. Serum creatinine<=upper limit of normal (ULN)
7. Urinary protein >= grade1 (+1) (11) Written informed consent.
(1) Hypersensitivity or History of the severe hypersensitivity for capecitabine, oxaliplatin or bevacizumab.
(2) Prior abdominal irradiation for colorectal cancer.
(3) CNS metastases or brain cancer confirmed by imaging (When it is suspected, imaging confirmation is required).
(4) Complication of cerebrovascular disease or its symptoms within 1 year.
(5) With sever complication (intestinal paralysis, intestinal obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, hypertension, cardiac failure, renal failure, liver dysfunction, and so on).
(6) With complication of history of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year.
(7) Massive pleural or ascites that required drainage.
(8) Uncontrolled peptic ulcer.
(9) Uncontrolled diarrhea.
(10) Uncontrolled infection.
(11) Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy or abnormality of coagulation factor
(12) Administrated antithrombotic drug or drug affected to congealing fibrinogenolysis system within 14 days before enrollment (Except for low-dose of aspirin.)
(13) Active multiple primary cancer.
(14) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
(15) With mental disorder or psychological symptoms which disturb registration to this study.
(16) Not appropriate for the study at the physician's assessment.
33
1st name | |
Middle name | |
Last name | Hirotoshi Hasegawa |
School of Medicine, Keio University
Department of Surgery
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
03-3353-1211
hasegawa@keio.jp
1st name | |
Middle name | |
Last name | Masashi Tsuruta |
School of Medicine, Keio University
Department of Surgery
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
03-3353-1211
masashitsuruta@z2.keio.jp
Department of Surgery, School of Medicine, Keio University
none
Self funding
NO
2011 | Year | 03 | Month | 03 | Day |
Unpublished
Terminated
2011 | Year | 01 | Month | 19 | Day |
2010 | Year | 12 | Month | 27 | Day |
2011 | Year | 02 | Month | 01 | Day |
2017 | Year | 01 | Month | 31 | Day |
2011 | Year | 03 | Month | 03 | Day |
2019 | Year | 09 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006155
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