UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015764 |
|---|---|
| Receipt number | R000018285 |
| Scientific Title | A phase I/II study of Lonsurf combined with Oxaliplatin in metastatic colorectal cancer patients refractory to standard chemotherapy. |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2019/03/11 00:12:12 |
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Basic information
Public title
A phase I/II study of Lonsurf combined with Oxaliplatin in metastatic colorectal cancer patients refractory to standard chemotherapy.
Acronym
LUPIN study
Scientific Title
A phase I/II study of Lonsurf combined with Oxaliplatin in metastatic colorectal cancer patients refractory to standard chemotherapy.
Scientific Title:Acronym
LUPIN study
Region
| Japan |
Condition
Condition
Metastatic Colorectal Cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
(Phase I part)
To determine the recommended dose (RD) and maximum tolerated dose (MTD) of Lonsurf combined with oxialiplatin (L-OHP) in metastatic colorectal cancer patients refractory or intolerant to standard chemotherapy with fluoropyrimidine, L-OHP, irinotecan (CPT-11), bevacizumab as anti-VEGF antibody and cetuximab/patitumumab as anti-EGFR antibody.
(Phase II part)
To evaluate the efficacy and safety of Lonsurf combined with L-OHP in patients with metastatic colorectal cancer refractory to standard chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
[Phase I part] To determine recommended dose (RD) and maximum tolerated dose (MTD)
[Phase II part] Disease Control Rate (DCR)
Key secondary outcomes
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
Lonsurf/L-OHP therapy
Lonsurf: 70mg/m2, d1-5, d15-19 (fixed dose)
L-OHP: 50-85mg/m2, d1,d15 (dose escalation)
every 4 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria are mainly as follows (regardless of gender):
1. Has adenocarcinoma of the colon or rectum
2. Metastatic colorectal cancer (except for appendiceal cancer and anal cancer)
3. Has evaluable tumor lesions (RECIST ver. 1.1)
4. Aged 20 to 80 years at the time of informed consent
5. ECOG performance status of 0 or 1
6. Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer (refractory or intolerant to standard chemotherapy with FUs, L-OHP, CPT-11, bevacizumab as anti-VEGF antibody and cetuximab/patitumumab as anti-EGFR antibody)
7. Is able to take medications orally
8. Survival for at least 12 weeks is expected.
9. On the basis of tests carried out within 14 days before enrollment, which may be on the same day of the week as the enrollment date but 2 weeks earlier, the principal organ functions are maintained, as defined by the following criteria:
a) Neurtophils>or=1500/mm3
b) Platelets>or=100,000/mm3
c) Hemoglobin>or=9.0g/dl
d) GOT(AST)=or<upper limit of normal (ULN)*2.5 (=or<ULN*5 in case of liver metastasis)
e) GPT(ALT) =or<upper limit of normal (ULN)*2.5 (=or<ULN*5 in case of liver metastasis)
f) Total bilirubin =or<upper limit of normal (ULN)*1.5
g) Serum creatinine =or<upper limit of normal (ULN)*1.5
10. Has provided written informed consent
Key exclusion criteria
The exclusion criteria are mainly as follows (regardless of gender):
1. Has received Lonsurf
2. History of discontinuation for adverse reaction (eg. serious peripheral neuropathy) by L-OHP
3. History of drug hypersensitivity (except for L-OHP)
4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
5. Has bleeding from the tumor which affect hemodynamics
6. Has sever peripheral neuropathy
7. Has synchronous multiple primary cancer within 5 years (except for carcinoma in situ )
8. Ascites, pulmonary and/or pericardial effusion requiring medical treatment
9. Has complication as follows
a) poorly controlled diabetes
b) uncontrolled hypertensions
c) cirrhosis, liver failure, renal insufficiency
d) intestinal paralysis, ileus
e) interstitial lung disease, pulmonary fibrosis, emphysema
f) active infection
g) cardiac disease
h) cerebrovascular disorder, brain metastasis
i) hemorrhagic ulcer
J) psychiatric disorder
10. Is a pregnant or lactating female
11. History of severe allergy
12. Amalgamation of mental disease or psychotic manifestation
13. The investigator considers not suitable for the study
Target sample size
41
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsukuni Suenaga |
Organization
Cancer Institute Hospital of the Japanese Foundation for Cancer Research.
Division name
Gastroenterology
Zip code
Address
3-8-31 Ariake, Koto-ku, Tokyo
TEL
+81-3-3520-0111
m.suenaga@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsukuni Suenaga |
Organization
Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Division name
Gastroenterology
Zip code
Address
3-8-31 Ariake, Koto-ku, Tokyo
TEL
+81-3-3520-0111
Homepage URL
m.suenaga@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Japanese Foundation for Cancer Research
Organization
Division
Category of Funding Organization
Other
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
公益財団法人 がん研究会有明病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s10637-019-00749-9
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
| 2014 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | 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
| 2014 | Year | 11 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018285
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| Registered date | File name |
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| Registered date | File name |
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