UMIN-CTR Clinical Trial

Public title

Phase I study of FOLFOXIRI+cetuximab in patients with RAS wild-type unresectable colorectal cancer

Acronym

Phase I study of FOLFOXIRI+cetuximab in patients with RAS wild-type unresectable colorectal cancer

Scientific Title

Phase I study of FOLFOXIRI+cetuximab in patients with RAS wild-type unresectable colorectal cancer

Scientific Title:Acronym

Phase I study of FOLFOXIRI+cetuximab in patients with RAS wild-type unresectable colorectal cancer

Region

Japan

Condition

RAS wild-type unresectable colorectal cancer

Classification by specialty

Gastroenterology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To determine maximaum tolerated dose and recommended dose of FOLFOXIRI+cetuximab.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

Recommended dose

Key secondary outcomes

Response rate
Safety

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

FOLFOXIRI+cetuximab (until 12 courses)
Cetuximab 400mg/m2/weekly (initial dose)
250mg/m2/weekly (maintenance)
Irinotecan 100-150mg/m2/bi-weekly
Oxaliplatin 85mg/m2/bi-weekly
5-FU 2400mg/m2/bi-weekly

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 confirmed colorectal cancer.
2) Measurable lesion by RECIST ver.1.1.
3) ECOG performance status 0-1.
4) No prior chemotherapy for unresectable disease.
5) RAS wild-type.
6) Life expectancy of more than 12 weeks.
7) Written informed consent.
8) Age; more than 20 years old and less than 75 years old.

Key exclusion criteria

1) Symptomatic brain metastasis.
2) Diarrhea greater than Grade 2.
3) Paralytic or mechanical bowel obstruction.
4) Confirmed orsuspected active infection.
5) Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema).
6) Serious complications (uncontrolled diabetes, heart failure with NYHA 3 or 4, renal failure, liver failure).
7) Coronary heart disease or myocardial infarction within 12 months prior to the registration.
8) Women who are pregnant or breastfeeding. Patients who are unwilling to avoid pregnancy.
9) Carcinomatous meningitis, uncontrolled convulsive attack, mental disorders, or clinically important CNS diseases.
10) Peripheral neuropathy greater than Grade 2.
11) UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28.
12) Administration of phenytoin, warfarin, or atazanavir sulfate.
13) History of severe drug-induced hypersensitivity syndrome.
14) History of hypersensitivity greater than Grade 2 after FOLFOX therapy.
15) Prior anti-EGFR antibodies.
16) Unrecoverd from surgey within 4 weeks prior to the registration.
17) Radiotherapy within 4 weeks prior to the registration.
18) massive pleural, abdominal, or cardiac effusion.
19) HBs-Ag(+), HCV-Ab(+), or HIV-Ab(+).
20) Active multiple malignancy.
21) Any other cases who are regarded as inadequate for study enrollment by investigators.

Target sample size

12

Name of lead principal investigator

1st name
Middle name
Last name	Kei Muro

Organization

Aichi Cancer Center Hospital

Division name

Department of Clinical Oncology

Zip code

Address

1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan

TEL

052-762-6111

Email

kmuro@aichi-cc.jp

Name of contact person

1st name
Middle name
Last name	Shigenori Kadowaki

Organization

Aichi Cancer Center Hospital

Division name

Department of Clinical Oncology

Zip code

Address

1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan

TEL

052-762-6111

Homepage URL

Email

skadowaki@aichi-cc.jp

Institute

Aichi Cancer Center Hospital

Institute

Department

Personal name

Organization

Aichi Cancer Center Hospital

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

愛知県がんセンター中央病院（愛知県）

Date of disclosure of the study information

2014

Year

11

Month

07

Day

URL releasing protocol

Publication of results

Partially published

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

09

Month

08

Day

Date of IRB

Anticipated trial start date

2014

Year

11

Month

07

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

11

Month

06

Day

Last modified on

2018

Year

05

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018151