Unique ID issued by UMIN | UMIN000009911 |
---|---|
Receipt number | R000011613 |
Scientific Title | A phaseI/II study of irinotecan with bevacizumab as second line treatment of elderly patients with metastatic colorectal cancer. |
Date of disclosure of the study information | 2013/01/30 |
Last modified on | 2018/08/14 01:16:16 |
A phaseI/II study of irinotecan with bevacizumab as second line treatment of elderly patients with metastatic colorectal cancer.
A phaseI/II study of irinotecan with bevacizumab as second line treatment of elderly patients with metastatic colorectal cancer.
A phaseI/II study of irinotecan with bevacizumab as second line treatment of elderly patients with metastatic colorectal cancer.
A phaseI/II study of irinotecan with bevacizumab as second line treatment of elderly patients with metastatic colorectal cancer.
Japan |
colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy and safety of the combination of Irinotecan + Bevacizumab as second-line chemotherapy in the patients aged 70 and over with unresectable advanced recurrent coloreatal cancer previously treated with Bevacizumab + fluorinated pyrimidine +/- L-OHP.
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
Phase I part
Estimated the dose limiting toxicities in 1st cycle.
Phase II part
Progression Free Survival
Safety
overall survival
overall response rate
disease control rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Irinotecan + Bevacizumab
70 | years-old | <= |
Not applicable |
Male and Female
(1)Written informed consent.
(2)Age and Eastern Cooperative Oncology Group (ECOG) performance status (PS) :
I.70-74:PS2
II.75<= : PS0-2
(3)Life expectancy greater than or equal to 3 months.
(4)Histological confirmation of colorectal cancer.
(5)Advanced or recurrent colorectal cancer that is not amenable to curative resection.
(6)Measurable or evaluable disease.
(7)Progression during or after first-line chemotherapy for metastatic disease, including bevacizumab with 5FU +/- L-OHP.
(8)Vital organ functions (listed below) are preserved within 2 weeks prior to entry.
I.Leukocyte count >=3,000/mm3
II.Neurtophils >=1,500/mm3
III.Platelets >=100,000/mm3
IV.Hemoglobin >=9.0g/dl
V.AST and ALT <=100IU/l
(200IU/l in case of liver metastasis)
VI.Total bilirubin <=2.0mg/dl
VII.Serum creatinine <=1.2mg/dl
VIII.Patients with UGT1A1 genotype wild type and *6,*28 heterozygote
(1)Need to drain malignant celomic fluid.
(2)Jaundice
(3)Paralytic or mechanical bowel obstruction.
(4)Receiving Atazanavir Sulfate
(5)Radiological evidence of CNS metastases or brain cancer.
(6)Multiple primary cancers within 5 years.
(7)Complication of cerebrovascular disease or symptoms within 1 year.
(8)Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week.
(9)Administering antithrombotic drug within 10 days.
(10)Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS).
(11)Evidence of bleeding diathesis or coagulopathy.
(12)Active gastrointestinal ulcer
(13)Current or previous (within the last 1 year) history of GI perforation.
(14)Non healing fracture
(15)Renal failure to be treated,3+ or higher proteinuria within 2 weeks prior to entry.
(16)Uncontrolled Hypertension
(17)Uncontrolled diabetes mellitus
(18)Clinically significant (i.e. active) cardiovascular disease or past or current history (within the last 1 year) of myocardial infarction.
(19)History of the serious hypersensitivity for bevacizumab.
(20)Evidence of interstinal lung disease, or pulmonary fibrosis.
(21)History of organ transplantation.
(22)Treatment history of irinotecan.
(23)Other conditions not suitable for this study.
25
1st name | |
Middle name | |
Last name | Yoshinori Sakai |
Tsuchiura kyodo general hospital
Department of Gastroenterology
11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan
1st name | |
Middle name | |
Last name | Toshiki Masuishi |
Tsuchiura kyodo general hospital
Department of Gastroenterology
11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan
Tsuchiura kyodo general hospital
none
Self funding
NO
2013 | Year | 01 | Month | 30 | Day |
Unpublished
Terminated
2013 | Year | 01 | Month | 17 | Day |
2013 | Year | 02 | Month | 01 | Day |
2013 | Year | 01 | Month | 30 | Day |
2018 | Year | 08 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011613