UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	PhaseI/II study of irinotecan and oxaliplatin combination chemotherapy in patients with gemcitabine and 5-fluorouracil refractory pancreatic cancer.
Title of the study (Brief title)	PhaseI/II study of IROX therapy in gemcitabine and 5-fluorouracil refractory pancreatic cancer.
Region	Japan

Condition
Condition	pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	phaseI:To determine the recommended dose for the phaseII study based on the ovserved dose-limiting toxicities. phaseII:To evaluate the efficacy and safety of irinotecan and oxaliplatin combination chemotherapy in patients with gemcitabine and 5-fluorouracil refractory pancreatic cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	phaseI:Safety,frequency of DLTs phaseII:Response Rate
Key secondary outcomes	phaseI:Response Rate frequency of adverse events phaseII:Overall Survival Progression-free Survival Disease Control Rate Safety

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	CPT-11:100,125,150mg/m2 day1, L-OHP:85mg/m2 day1, q2w
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	20 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma. (2)Refractory or intolerance for gemcitabine and 5-fluorouracil as previous chemothrapy. (3)Age;20 to 79 years old (4)ECOG PS;0-1 (5)Measurable lesions defined by RECIST. (6)Written informed consent. (7)Adequate organ function.
Key exclusion criteria	(1)Severe complications. (2)Grade2 or greater peripheral neuropathy. (3)Patients who received blood transfusions or hematopoietic growth factors within 7 days before the laboratory test (4)Active infections. (5)Pulmonary fibrosis or interstitial pneumonia. (6)Clinically evident pleural, abdominal or cardiac effusion. (7)Watery diarrhea within 3days before registration. (8)Surgery within 4weeks,chemotherapy within 2 weeks,radiation therapy within 2 weeks. (9)Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies. (10)Poorly controlled diabetes. (11)Brain metastasis. (12)Severe mental disorder. (13)Double advanced cancer. (14)Severe drug allergies. (15)pregnant or lactating female. (16)Current use atazanavir. (17)Concurrent chronic systemic steroid treatment. (18)Having UGT1A1*6/*6,UGT1A1*28/*28 or UGT1A1*6/*28 gene (19)Prior therapy with irinotecan or oxaliplatin. (20)Inappropriate for entry onto the study,as diagnosed by primary physician.
Target sample size	30

Research contact person
Name of lead principal investigator	Kentaro Sudo
Organization	Chiba cancer center
Division name	Department of Gastroenterology
Address	666-2 Nitona cho,Chiba City,Chiba,Japan
TEL	043-264-5431
Email	ksudo@chiba-cc.jp

Public contact
Name of contact person	Akiko Tsujimoto
Organization	Chiba cancer center
Division name	Department of Gastroenterology
Address	666-2 Nitona cho,Chiba City,Chiba,Japan
TEL	043-264-5431
Homepage URL
Email	atsujimoto@chiba-cc.jp

Sponsor
Institute	Chiba cancer center
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	2014 Year 12 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2017 Year 05 Month 15 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	2014 Year 12 Month 08 Day
Last modified on	2018 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018443