UMIN-CTR Clinical Trial

Public title

Phase I study of third-line FOLFIRINOX (oxaliplatin, irinotecan, 5-FU, and leucovorin) unresectable Gem/S-1 refractory pancreatic adenocarcinoma

Acronym

Phase I study of third-line FOLFIRINOX for pancreatic adenocarcinoma

Scientific Title

Phase I study of third-line FOLFIRINOX (oxaliplatin, irinotecan, 5-FU, and leucovorin) unresectable Gem/S-1 refractory pancreatic adenocarcinoma

Scientific Title:Acronym

Phase I study of third-line FOLFIRINOX for pancreatic adenocarcinoma

Region

Japan

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

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

Primary outcomes

occurrence of side effect of preoperative gemcitabine based chemoradiation therapy

Key secondary outcomes

Response Rate, Overall Survival (OS) , Progression free survival (PFS)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Tatsuya Ioka

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Division of Hepatobiliary and Pancreatic Oncology

Zip code

Address

3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan

TEL

06-6972-1181

Email

ioka-ta@mc.pref.osaka.jp

Name of contact person

1st name
Middle name
Last name	Tatsuya Ioka

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Division of Hepatobiliary and Pancreatic Oncology

Zip code

Address

3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan

TEL

06-6972-1181

Homepage URL

Email

ioka-ta@mc.pref.osaka.jp

Institute

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

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

03

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2014

Year

02

Month

01

Day

Date of IRB

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

Other related information

Registered date

2016

Year

03

Month

18

Day

Last modified on

2016

Year

04

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024550