UMIN-CTR Clinical Trial

Public title

Phase II crinical trial of panitumumab rechallenge with KRAS wild-type unresectable/recurrent colorectal cancer.

Acronym

Panitumumab Rechallenge

Scientific Title

Phase II crinical trial of panitumumab rechallenge with KRAS wild-type unresectable/recurrent colorectal cancer.

Scientific Title:Acronym

Panitumumab Rechallenge

Region

Japan

Condition

Colorectal Cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

This phase II prospective study aims to investigate the activity of a retreatment with a Panitumumab-based therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Response rate(RR)

Key secondary outcomes

Progression free survival(PFS)
Overall survival(OS)
Safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

This is a multicentric phase II trial that examines patients who had a clinical benefit [confirmed stable disease (SD) for at least 6 months or clinical response] after a line of panitumumab-plus FOLFOX/FOLFIRI therapy and then a progression of disease, during panitumumab -based therapy, for which underwent a new line chemotherapy and finally, after a clear new progression of disease, were retreated with the same or another panitumumab based chemotherapy.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Histopathological confirmation of Adenocarcinoma
2)KRAS wild type (in codon 12, 13) confirmed, either in the primary tumor or in metastatic tumor lesion
3)Patients who had a clinical benefit [confirmed stable disease (SD) for at least 6 months or clinical response] after a line of panitumumab based chemotherapy and then a progression of disease or intolerable of adverse events, during panitumumab based chemotherapy, for which underwent a new line chemotherapy and finally, after a clear new progression of disease, were retreated with the same or another panitumumab chemotherapy.
4)Age of 20 or more years old
5)ECOG performance status of 0 to 2
6)Presence of at least one measurable lesion according to RECIST
7)Sufficient function of important organs
1. WBC:>= 2,000 /mm3
2. Neu: >= 1,500 /mm3
3. Platelet: >= 75,000 /mm3
4. Hemoglobin: >= 8.0 g/dL
5. Sr.bil : <= 2.5 mg/dL
6. AST, ALT: <= upper limits of normal (ULN)x2.5 (patients with liver metastasis; AST, ALT : <= ULNx5.0)
7. Serum creatinine: <= ULNx1.5
8. Ccr: > 50ml/min for the patients who are treated by TS-1, > 30ml/min for the patients who are treated by Cpecitabine,
8) Expected more than 3 months survival
9)With written informed consent

Key exclusion criteria

1)Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
2)Patients with brain metastasis which have symptoms or patients with history of brain metastasis
3)Severe wattery diarrhea
4)Severe infectious disease
5)Severe complications (interstitial lung disease or pulmonary fibrosis, kidney failure, hepatic failure, uncontrolable diabetes, uncontrolable hypertension)
6)Severe carcinomatous ascites, pleural effusion or pericardial cavity effusion
7)Pregnant or lactating women or women of childbearing potential, and no birth-control
8)Patients with history of serious hypersensitivity

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Toshiyoshi Fujiwara

Organization

Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences

Division name

Department of Gastroenterological Surgery

Zip code

Address

2-5-1, Shikata-cho, Kita-ku, Okayama, Japan

TEL

086-235-7257

Email

Name of contact person

1st name
Middle name
Last name	Takeshi Nagasaka

Organization

Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences

Division name

Department of Gastroenterological Surgery

Zip code

Address

TEL

086-235-7257

Homepage URL

Email

Institute

Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences

Institute

Department

Personal name

Organization

Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences

Organization

Division

Category of Funding Organization

Self funding

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

2013

Year

06

Month

13

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

Terminated

Date of protocol fixation

2013

Year

05

Month

29

Day

Date of IRB

Anticipated trial start date

2013

Year

06

Month

13

Day

Last follow-up date

2017

Year

06

Month

12

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

06

Month

13

Day

Last modified on

2018

Year

06

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012818