UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phaseI/II study of irinotecan with bevacizumab as second line treatment of elderly patients with metastatic colorectal cancer.
Title of the study (Brief title)	A phaseI/II study of irinotecan with bevacizumab as second line treatment of elderly patients with metastatic colorectal cancer.
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I part Estimated the dose limiting toxicities in 1st cycle. Phase II part Progression Free Survival
Key secondary outcomes	Safety overall survival overall response rate disease control rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Irinotecan + Bevacizumab
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(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
Key exclusion criteria	(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.
Target sample size	25

Research contact person
Name of lead principal investigator	Yoshinori Sakai
Organization	Tsuchiura kyodo general hospital
Division name	Department of Gastroenterology
Address	11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan
TEL
Email

Public contact
Name of contact person	Toshiki Masuishi
Organization	Tsuchiura kyodo general hospital
Division name	Department of Gastroenterology
Address	11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Tsuchiura kyodo general hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 30 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 01 Month 17 Day
Anticipated trial start date	2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 01 Month 30 Day
Last modified on	2018 Year 08 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011613