Unique ID issued by UMIN | UMIN000010319 |
---|---|
Receipt number | R000012078 |
Scientific Title | Phase II study of TS-1+Irinotecan+Bevacizumab as second-line treatment in patients with metastatic colorectal cancer refractory to fluoronated pyrimidine, oxaliplatin, and cetuximab therapy |
Date of disclosure of the study information | 2013/03/26 |
Last modified on | 2016/11/24 15:00:59 |
Phase II study of TS-1+Irinotecan+Bevacizumab as second-line treatment in patients with metastatic colorectal cancer refractory to fluoronated pyrimidine, oxaliplatin, and cetuximab therapy
JACCRO CC-07 study
Phase II study of TS-1+Irinotecan+Bevacizumab as second-line treatment in patients with metastatic colorectal cancer refractory to fluoronated pyrimidine, oxaliplatin, and cetuximab therapy
JACCRO CC-07 study
Japan |
Metastatic colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy and safety of TS-1+irinotecan+bevacizumab as second-line treatment in metastatic colorectal cancer refractory to fluonated pyrimidine, oxaliplatin, and cetuximab therapy
Safety,Efficacy
Exploratory
Pragmatic
Phase II
6-Month Progression Free Survival Rate
Overall Survival
Progression Free Survival
Response Rate
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
TS-1+Irinotecan+Bevacizumab therapy
Bevacizumab 7.5mg/m2/tri-weekly
Irinotecan 150mg/m2/tri-weekly
TS-1 80-120mg/day, for 14 days followed by 1 week rest
20 | years-old | <= |
Not applicable |
Male and Female
(1)Patients with histologically proven colorectal cancer
(2)Metastatic colorectal cancer refractory to fluoronated pyrimidine, oxaliplatin, and cetuximab therapy as first-line
(3)Presence of evaluable lesion
(4)ECOG Performance Status 0-1
(5)Age equal more 20 years old
(6)Life expectancy of more than 3 months
(7)Oral food intake possible
(8)Patiens have enough organ function for study treatment within 14 days before enrollment
WBC>=3,000/mm3, <12,000/mm3
Neu>=1,500/mm3
PLT>=10.0x104/mm3
Hb>=9.0g./dL
Total Bilirubin <= 1.5mg/dL
AST<=100 IU/L
ALT<=100 IU/L
Creatinine <=1.2mg/dL
Creatinine clearance >=50mL/min
Proteinuria<=2+
PT-INR <=1.5
(9)Written informed consent
(1)Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval
(2)Symptomatic brain metastases
(3)Infectious disease
(4)Interstitial lung disease or pulmonary fibrosis
(5)Comorbidity or history of heart failure
(6)History of thromboembolic events
(7)History of hemoptysis
(8)Sensory alteration or paresthesia interfering with function
(9)Large quantity of pleural, abdominal or cardiac effusion
(10)Severe comorbidity (renal failure, liver failure, hypertension, etc)
(11)Prior radiotherapy for primary and metastases tumors
(12)Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breast feeding. Women with a positive pregnancy test
(13)History of severe allergy
(14)Surgical procedure or such as skin-open biopy, trauma surgery, or other more intensive surgeries within 4 weeks
(15)Systemic administration of antiplatelet drug or NSAIDs
(16)Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy
(17)Uncontrolled peptic ulcer
(18)History of gastrointestinal perforation within 1 year
(19)Untreated traumatic bone fracture
(20)Require treatment of renal dysfunction
(21)Doubting dihydropyrimidine dehydrogenase deficit
(22) Uncontrolled diarrhea
(23)History of organ recipient
(24)Administration of atazanavir sulfate
(25Administration of flucytosine
(26)Jaundice
(27) Ileus or bowel obstruction
(28)Any other cases who are regarded as inadequate for study enrollment by investigators
70
1st name | |
Middle name | |
Last name | Ken Shimada |
Showa University Koto Toyosu Hospital
Department of Internal Medicine
5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan
03-6204-6000
shimakenken60@hotmail.com
1st name | |
Middle name | |
Last name | Masashi Fujii |
Japan Clinical Cancer Research Organization
Office
7F, 1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
03-5579-9882
cc07.dc@jaccro.or.jp
Japan Clinical Cancer Research Organization
Japan Clinical Cancer Research Organization
Non profit foundation
Japan
NO
2013 | Year | 03 | Month | 26 | Day |
Partially published
No longer recruiting
2013 | Year | 03 | Month | 06 | Day |
2013 | Year | 03 | Month | 06 | Day |
2013 | Year | 03 | Month | 26 | Day |
2016 | Year | 11 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012078