UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003819 |
|---|---|
| Receipt number | R000004604 |
| Scientific Title | A phase ll study of combination therapy with Panitumumab plus CPT-11 for advanced and/or recurrent colon-rectal cancer with wild type KRAS which has prior therapy of fluoropylimidine, oxaliplatin or CPT-11 (OGSG 1001) |
| Date of disclosure of the study information | 2010/07/15 |
| Last modified on | 2020/01/05 13:38:53 |
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Basic information
Public title
A phase ll study of combination therapy with Panitumumab plus CPT-11 for advanced and/or recurrent colon-rectal cancer with wild type KRAS which has prior therapy of fluoropylimidine, oxaliplatin or CPT-11 (OGSG 1001)
Acronym
A phase ll study of combination therapy with Panitumumab plus CPT-11 for advanced and/or recurrent colon-rectal cancer with wild type KRAS which has prior therapy of fluoropylimidine, oxaliplatin or CPT-11 (OGSG 1001)
Scientific Title
A phase ll study of combination therapy with Panitumumab plus CPT-11 for advanced and/or recurrent colon-rectal cancer with wild type KRAS which has prior therapy of fluoropylimidine, oxaliplatin or CPT-11 (OGSG 1001)
Scientific Title:Acronym
A phase ll study of combination therapy with Panitumumab plus CPT-11 for advanced and/or recurrent colon-rectal cancer with wild type KRAS which has prior therapy of fluoropylimidine, oxaliplatin or CPT-11 (OGSG 1001)
Region
| Japan |
Condition
Condition
colon-rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To confirm the feasibility and effectiveness of Panitumumab plus CPT-11 for advanced and/or recurrent colon cancer with wild type KRAS which are resistant/intolerant oxaliplatin,furuoropyrimidine and/or PD on CPT-11 therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Responce rate(RECIST)
Key secondary outcomes
Disease control rate (CR+PR+SD/ FAS)
Progression free survival
overall survival
Time to progression
Adverse events
Biomarkers on the specimen
pharmakokinetics
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
One course includes
Panitumumab 6mg/kg and Irinotecan 150mg/m2 on day 1 and 14 days rest.
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
Eligibility Criteria
1.Histologically proven colon cancer or rectal cancer except appendical cancer or anal cancer
2.genetically proven KRAS wild type on the tumor tissue
3.with measurable lesions for RECIST criteria
4.patients with tumor resistant/intolerant to oxaliplatin, fluoropyrimidine and/or PD on CPT-11 therapy
*resistant/intolerant: PD on the therapy or recurrence within 6 months after the adjuvant therapy. Stop of treatment due to allergic reaction, withdrawal neuro-toxicity and/or other toxic events
5.An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1,or 2.
6.A predicted life expectancy of at least 8 weeks
7.with rest period of treatment
a.2 weeks for radiation therapy
b.2 weeks for surgical resection
c.2 weeks for chemotherapy
d.2 weeks for hormone therapy and/or immune therapy
e.2 weeks for cytokine therapy and/or BRM therapy
8. with a good condition of important organs
a.neutrophil >= 1,000/mm3
b.platelet >= 100,000/mm3
c.ALT/AST <= 2.5 times of normal limit
d.total bilirubin <= 1.5mg/dl
e.creatinine <= 2.0mg/dl
9. Written informed consent to participate in this study
Key exclusion criteria
Exclusion Criteria
1. with symptom of brain metastasis
2.diarrhea (watery stool)
3.intestinal paralysis and/or obstruction
4.with infectious diseases or febrile condition
5.with severe pulmonary diseases (interstitial pneumonitis, pulmonary fibrosis or severe pneumothorax)
6.with severe diseases (uncontrollable DM, heart failure severe than NYHA II, renal failure, and/or liver dysfunction)
7.ladies pregnant and/or nursing baby, or ladies who have plans to have babies.
8.with carcinomatous menigitis, uncontrollable spasms (continuous spasms due to epilepsy) and/or history of mental disorder
9.with grade 3 neural disorder
10.administration of contraindicative medicines
11.history of grade 3 allergy due to CPT-11
12.history of administration of antagonisms to EGF signal and/or anti-EGFR medicines
13.any other patient whom the physician in charge of the study judges to be unsuitable
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Goto |
Organization
Osaka Medical College Hospital
Division name
chemotherapy center
Zip code
Address
2-7 Daigakucho takatsuki City Osaka
TEL
072-683-1221
in2030@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Furukawa |
Organization
Kinki University School of Medicine
Division name
Department of surgery
Zip code
Address
377-2, Onohigashi, Osakasayama, Osaka, Japan
TEL
072-366-0221
Homepage URL
hiroshi.furukawa@tokushukai.jp
Sponsor or person
Institute
Osaka Gastrointestinal cancer chemotherapy Study Group(OGSG)
Institute
Department
Personal name
Funding Source
Organization
Osaka Clinical Study Supporting Organization
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
| 2010 | Year | 07 | Month | 15 | 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
The 11th Annual Meeting of Japanese Society of Medical Oncology
Japan Digestive Deasese Week 2013
2014 Gastrointestinal Cancers Symposium
ESMO World Congress on Gastrointestinal Cancer 2014
The 52th Annual Meeting of Japanese Society of Clinical Oncology
The 12th Annual Meeting of Japanese Society of Medical Oncology
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
| 2010 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2010 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2010 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 24 | Day |
Last modified on
| 2020 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004604
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| Registered date | File name |
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