UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007191 |
|---|---|
| Receipt number | 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 08:24:09 |
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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
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
hmishima@aichi-med-u.ac.jp
Public contact
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
miya@ecrin.or.jp
Sponsor or person
Institute
Epidemiological and Clinical research Information Network (ECRIN)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008249
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
