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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007191
Receipt No. R000008249
Scientific Title Phase II Study of Panitumumab with Fluorouracil in Patients With KRAS Wild-type Metastatic Colorectal Cancer(PF Study)
Date of disclosure of the study information 2012/02/01
Last modified on 2018/09/20

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Basic information
Public title Phase II Study of Panitumumab with Fluorouracil in Patients With KRAS Wild-type Metastatic Colorectal Cancer(PF Study)
Acronym Phase II Study of Panitumumab with Fluorouracil in Patients With KRAS Wild-type Metastatic Colorectal Cancer
(PF Study)
Scientific Title Phase II Study of Panitumumab with Fluorouracil in Patients With KRAS Wild-type Metastatic Colorectal Cancer(PF Study)
Scientific Title:Acronym Phase II Study of Panitumumab with Fluorouracil in Patients With KRAS Wild-type Metastatic Colorectal Cancer
(PF Study)
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of panitumumab with fluorouracil in patients with KRAS wild-type metastatic colorectal cancer. And, to investigate the relationship of early response of panitumumab and clinical examination data.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Disease control rate
Progression-free survival
Adverse events
Biomarkers on clinical examination data

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 l-LV 200mg/m2 day 1
5-FU/bolus 400mg/m2 day1
5-FU/infusional 2,400mg/m2 day1-2
Panitumumab 6mg/kg day 1
Biweekly

or
Capecitabine 2,000mg/m2/day day1-7
Panitumumab 6mg/kg day1
Biweekly

or
S-1 80mg/m2/day day1-7
Panitumumab 6mg/kg day1
Biweekly

or
UFT 300mg/m2/day day1-7
LV 75 mg/m2/day day1-7
Panitumumab 6mg/kg day1
Biweekly

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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically confirmed colorectal cancer
2)KRAS wild type
3)Measurable lesion based on RECIST
ver1.1.
4)Not appropreate for combination therapy with fluorouracil and oxaliplatin or irinotecan
5)Age of at least 20 years.
6)ECOG PS of 0 - 2
7)Adequate organ functions
a)WBC=>2000/mm3
b)Neutrophil=>1000/mm3
c)Platelet count>=7.5*104/mm3
d)Hemoglobin>=8.0 g/dL
e)Total bilirubin<=2*ULN
f)AST ALT<= 100 lU/L(Liver Met; AST, ALT<=199lU/L)
g)Creatinine<=2*ULN
h)Urine protein<= 2+
8)A life expectancy of more than 8 weeks
9) Written informed consent
Key exclusion criteria 1) Symptoms of brain metastasis
2) Uncontrolled diarrhea
3) Ireus
4) Infectious
5) Serious pulmonary diseases (interstitial pneumonia, pulmonary fibrosis or severe pneumothorax)
6) With serious diseases (uncontrolled DM, heart failure, renal failure, and/or liver dysfunction)
7) Ladies pregnant and/or nursing baby, or ladies who have plans to have babies.
8) Carcinomatous menigitis, and/or history of mental disorder
9) Neuropathy of more than grade 3
10) Administration of contraindicative medicines
11) Previously treated by anti-EGFR medicines
12) Other conditions not suitable for this study

Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hideyuki Mishima
Organization Aichi Medical University
Division name Cancer Center
Zip code
Address 1-1, Yazakokarimata, Nagakute, Aichi
TEL 0561-62-3311
Email hmishima@aichi-med-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yumi Miyashita
Organization Epidemiological and Clinical research Information Network (ECRIN)
Division name ECRIN Data Center
Zip code
Address 1-7-9 Hanenishi Okazaki, aichi JAPAN
TEL 0564-66-1220
Homepage URL
Email miya@ecrin.or.jp

Sponsor
Institute Epidemiological and Clinical research Information Network (ECRIN)
Institute
Department

Funding Source
Organization Epidemiological and Clinical research Information Network (ECRIN)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Munemoto Y. A phase II trial to evaluate the efficacy of panitumumab combined with fluorouracil-based chemotherapy for metastatic colorectal cancer: the PF trial.
Cancer Chemother Pharmacol. 2018 May;81(5):829-838.

Results:
Forty patients(male, 64.5%; median age,74 years; colon cancer, 72.5%)met eligibility criteria and received 7 cycles(median) of fluorouracil chemotherapy combined with panitumumab. There were no treatment-related deaths. Median time to treatment failure was 3.2 manths. 23(57.5%) patients experienced at least one adverse effect>grade3.The response rate was 10.0% (95% confidence interval 2.8-23.7%). Median progression-free survival and overall survival were 4.3 and 11.3 months, respectively. Total lactase dehydrogenase (LDH) levels and those of LDH-4 and LDH-5, quickly changed with disease reduction or progression. 
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

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 02 Month 01 Day
Last modified on
2018 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008249

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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