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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000450
Receipt No. R000000546
Scientific Title Phase I/II study on combination therapy consisting of a fixed dose-rate infusion of gemcitabine with oral fluorinated pyrimidine compound S-1 (FGS) in patients with gemcitabine-refractory advanced pancreatic cancer
Date of disclosure of the study information 2006/07/20
Last modified on 2011/07/18

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Basic information
Public title Phase I/II study on combination therapy consisting of a fixed dose-rate infusion of gemcitabine with oral fluorinated pyrimidine compound S-1 (FGS) in patients with gemcitabine-refractory advanced pancreatic cancer
Acronym Phase I/II study on combination therapy consisting of a fixed dose-rate infusion of gemcitabine with S-1 (FGS) in patients with gemcitabine-refractory advanced pancreatic cancer
Scientific Title Phase I/II study on combination therapy consisting of a fixed dose-rate infusion of gemcitabine with oral fluorinated pyrimidine compound S-1 (FGS) in patients with gemcitabine-refractory advanced pancreatic cancer
Scientific Title:Acronym Phase I/II study on combination therapy consisting of a fixed dose-rate infusion of gemcitabine with S-1 (FGS) in patients with gemcitabine-refractory advanced pancreatic cancer
Region
Japan

Condition
Condition Patients with gemcitabine-refractory metastatic pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of a combination therapy consisting of a fixed dose-rate infusion of gemcitabine with oral fluorinated pyrimidine compound S-1 (FGS) in patients with gemcitabine-refractory advanced pancreatic cancer to determine the recommended dose (RD) and maximum tolerated dose (MTD), and to evaluate the efficacy of the treatment regimen at the RD.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Phase 1: Rate of dose-limiting toxicity
Phase 2: Response rate
Key secondary outcomes Toxicity, Progression free survival, Overall survival

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 Gemcitabine,Day1
Level 0:600 mg/m2/60 min
Level 1:800 mg/m2/80 min
Level 2:1000 mg/m2/100 min
Level 3:1200 mg/m2/120 min
Level 4:1200 mg/m2/120 min

S-1, Days 1 - 7
Level 0:dose A
Level 1:dose A
Level 2:dose A
Level 3:dose A
Level 4:dose B

BSA / daily dose A / daily dose B
<=1.25 m2 / 80 mg / 100 mg
1.25 m2 - 1.5 m2 / 100 mg / 120 mg
>1.5 m2 / 120 mg / 150 mg
Repeat every 2 weeks.
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 adenocarcinoma
2) Progression during GEM-based first-line chemotherapy
3) Oral intake is possible
4) Measurable or assessable metastatic lesion(s)
5) Age of more than 20 years
6) ECOG performance status (PS) of 0 to 2
7) Interval of at least 2 weeks between last chemotherapy treatment and start of present chemotherapy regimen
8) Adequate organ function
a. WBC : 3,500/mm3
b. neutrophils : 1,500/mm3
c. platelets : 100,000/mm3
d. Hb : 9.0 g/dL
e. T-Bil : 2.0 mg/dL
f. GOT, GPT : 100 U/L
g. Cr : 1.1 mg/dL
9) Written informed consent
Key exclusion criteria 1) Regular use of fenitoin, warfarin or frucitocin
2) History of fluorinated pyrimidine use
3) Severe diarrhea
4) Severe mental disorder
5) Severe infection
6) Severe complication
7) Intestinal pneumonia or lung fibrosis
8) History of chest radiotherapy
9) Massive pleural or abdominal effusion
10) Symptomatic brain metastasis
11) History of other active malignancy
12) Pregnancy or the desire to preserve fecundity
13) Inadequate physical condition, as diagnosed by primary physician
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chigusa Morizane
Organization National Cancer Center Hospital
Division name Hepatobiliary and Pancreatic Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045, Japan
TEL 0335422511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chigusa Morizane
Organization National Cancer Center Hospital
Division name Hepatobiliary and Pancreatic Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045, Japan
TEL 03-3542-2511
Homepage URL
Email cmorizan@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
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
2006 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
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

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2006 Year 06 Month 01 Day
Last follow-up date
2008 Year 05 Month 01 Day
Date of closure to data entry
2009 Year 03 Month 01 Day
Date trial data considered complete
2009 Year 09 Month 01 Day
Date analysis concluded
2010 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 07 Month 18 Day
Last modified on
2011 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000546

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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