UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of third-line FOLFIRINOX (oxaliplatin, irinotecan, 5-FU, and leucovorin) unresectable Gem/S-1 refractory pancreatic adenocarcinoma
Title of the study (Brief title)	Phase I study of third-line FOLFIRINOX for pancreatic adenocarcinoma
Region	Japan

Condition
Condition	unresectable Gem/S-1 refractory pancreatic adenocarcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the maximum tolerated dose (MTD) and to evaluate the safety of third-line FOLFIRINOX (oxaliplatin, irinotecan, 5-FU, and leucovorin) for unresectable Gem/S-1 refractory pancreatic adenocarcinoma patients
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	occurrence of side effect of preoperative gemcitabine based chemoradiation therapy
Key secondary outcomes	Response Rate, Overall Survival (OS) , Progression free survival (PFS)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	This dose-escalation study was conducted as a phase I trial with a 3+3 design to estimate MTD of third-line FOLFIRINOX. Level1(L-OHP 55mg/m2, CPT-11 75mg/m2, 5FU 1200mg/m2 ) Level2(L-OHP 55mg/m2, CPT-11 75mg/m2, 5FU 1800mg/m2 ) Level3(L-OHP 55mg/m2, CPT-11 100mg/m2, 5FU 1800mg/m2 ) Level4(L-OHP 65mg/m2, CPT-11 100mg/m2, 5FU 1800mg/m2 ) Level5(L-OHP 65mg/m2, CPT-11 100mg/m2, 5FU 2400mg/m2 ) Level6(L-OHP 65mg/m2, CPT-11 120mg/m2, 5FU 2400mg/m2 ) Level7(L-OHP 85mg/m2, CPT-11 120mg/m2, 5FU 2400mg/m2 ) Level8(L-OHP 85mg/m2, CPT-11 150mg/m2, 5FU 2400mg/m2 ) Level9(L-OHP 85mg/m2, CPT-11 180mg/m2, 5FU 2400mg/m2 ) Level10(L-OHP 85mg/m2, CPT-11 180mg/m2, 5FU 2400mg/m2 )
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma 2. Performance Status 0-1 (ECOG) 3. WBC <=12,000/mm3 Neutrophils >=1,500/mm3 Platelets >=100,000/mm3 Hemoglobin >=9.0g/dL GOT, GPT: less than 3-fold of the upper limit of normal range Total bilirubin <3.0mg/dL Albumin >=3.5g/dL Creatinine clearance >=50ml/min 4. Life expectancy of at least 3 months 5. Written informed consent
Key exclusion criteria	1. Poorly controlled ascites 2. Patients homozygous for UGT1A1*6 or UGT1A1*28, or double heterozygotes (*6/*28) 3. Active infection 4. Lung fibrosis or intestinal pneumonia detectable on chest X-ray and CT 5. Severe complication (heart disease, cirrhosis, diabetes) 6. Myocardial infarction within 3 months 7. Active synchronous or metachronous malignancy, excluding intramucosal carcinoma 8. Pregnant or lactation women, or women with known or suspected pregnancy 9. Symptomatic brain metastasis 10. history of severe drug allergy 11. Grade 2 or higher peripheral sensory neuropathy 12. Impossible to implant the central venous port 13.Patients who are judged inappropriate for the entry into the study by the investigator
Target sample size	60

Research contact person
Name of lead principal investigator	Tatsuya Ioka
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Division of Hepatobiliary and Pancreatic Oncology
Address	3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL	06-6972-1181
Email	ioka-ta@mc.pref.osaka.jp

Public contact
Name of contact person	Tatsuya Ioka
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Division of Hepatobiliary and Pancreatic Oncology
Address	3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL	06-6972-1181
Homepage URL
Email	ioka-ta@mc.pref.osaka.jp

Sponsor
Institute	Osaka Medical Center for Cancer and Cardiovascular Diseases Division of Hepatobiliary and Pancreatic Oncology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	2016 Year 03 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 01 Day
Anticipated trial start date	2014 Year 03 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	2016 Year 03 Month 18 Day
Last modified on	2016 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000024550