UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000450 |
|---|---|
| Receipt number | 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 21:58:39 |
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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
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
cmorizan@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000546
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