UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015877 |
|---|---|
| Receipt number | R000018443 |
| Scientific Title | PhaseI/II study of irinotecan and oxaliplatin combination chemotherapy in patients with gemcitabine and 5-fluorouracil refractory pancreatic cancer. |
| Date of disclosure of the study information | 2014/12/10 |
| Last modified on | 2018/12/19 09:30:07 |
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Basic information
Public title
PhaseI/II study of irinotecan and oxaliplatin combination chemotherapy in patients with gemcitabine and 5-fluorouracil refractory pancreatic cancer.
Acronym
PhaseI/II study of IROX therapy in gemcitabine and 5-fluorouracil refractory pancreatic cancer.
Scientific Title
PhaseI/II study of irinotecan and oxaliplatin combination chemotherapy in patients with gemcitabine and 5-fluorouracil refractory pancreatic cancer.
Scientific Title:Acronym
PhaseI/II study of IROX therapy in gemcitabine and 5-fluorouracil refractory pancreatic cancer.
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
phaseI:To determine the recommended dose for the phaseII study based on the ovserved dose-limiting toxicities.
phaseII:To evaluate the efficacy and safety of irinotecan and oxaliplatin combination chemotherapy in patients with gemcitabine and 5-fluorouracil refractory pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
phaseI:Safety,frequency of DLTs
phaseII:Response Rate
Key secondary outcomes
phaseI:Response Rate
frequency of adverse events
phaseII:Overall Survival
Progression-free Survival
Disease Control Rate
Safety
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
CPT-11:100,125,150mg/m2 day1,
L-OHP:85mg/m2 day1,
q2w
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma.
(2)Refractory or intolerance for gemcitabine and 5-fluorouracil as previous chemothrapy.
(3)Age;20 to 79 years old
(4)ECOG PS;0-1
(5)Measurable lesions defined by RECIST.
(6)Written informed consent.
(7)Adequate organ function.
Key exclusion criteria
(1)Severe complications.
(2)Grade2 or greater peripheral neuropathy.
(3)Patients who received blood transfusions or hematopoietic growth factors within 7 days before the laboratory test
(4)Active infections.
(5)Pulmonary fibrosis or interstitial pneumonia.
(6)Clinically evident pleural, abdominal or cardiac effusion.
(7)Watery diarrhea within 3days before registration.
(8)Surgery within 4weeks,chemotherapy within 2 weeks,radiation therapy within 2 weeks.
(9)Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies.
(10)Poorly controlled diabetes.
(11)Brain metastasis.
(12)Severe mental disorder.
(13)Double advanced cancer.
(14)Severe drug allergies.
(15)pregnant or lactating female.
(16)Current use atazanavir.
(17)Concurrent chronic systemic steroid treatment.
(18)Having UGT1A1*6/*6,UGT1A1*28/*28 or UGT1A1*6/*28 gene
(19)Prior therapy with irinotecan or oxaliplatin.
(20)Inappropriate for entry onto the study,as diagnosed by primary physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Sudo |
Organization
Chiba cancer center
Division name
Department of Gastroenterology
Zip code
Address
666-2 Nitona cho,Chiba City,Chiba,Japan
TEL
043-264-5431
ksudo@chiba-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Tsujimoto |
Organization
Chiba cancer center
Division name
Department of Gastroenterology
Zip code
Address
666-2 Nitona cho,Chiba City,Chiba,Japan
TEL
043-264-5431
Homepage URL
atsujimoto@chiba-cc.jp
Sponsor or person
Institute
Chiba cancer center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2014 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Terminated
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 15 | 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
| 2014 | Year | 12 | Month | 08 | Day |
Last modified on
| 2018 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018443
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| Registered date | File name |
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