UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003176 |
|---|---|
| Receipt number | R000003851 |
| Scientific Title | Phase I study of a combination of capecitabine plus CPT-11 (CC therapy) in patients with metastatic colon cancer refractory to oxaliplatin containing chemotherapy |
| Date of disclosure of the study information | 2010/02/12 |
| Last modified on | 2017/02/21 18:23:22 |
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Basic information
Public title
Phase I study of a combination of capecitabine plus CPT-11 (CC therapy) in patients with metastatic colon cancer refractory to oxaliplatin containing chemotherapy
Acronym
Phase I study of a combination of capecitabine plus CPT-11 (CC therapy) in patients with metastatic colon cancer refractory to oxaliplatin containing chemotherapy
Scientific Title
Phase I study of a combination of capecitabine plus CPT-11 (CC therapy) in patients with metastatic colon cancer refractory to oxaliplatin containing chemotherapy
Scientific Title:Acronym
Phase I study of a combination of capecitabine plus CPT-11 (CC therapy) in patients with metastatic colon cancer refractory to oxaliplatin containing chemotherapy
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility of the combination of capecitabine plus irinotecan (CC therapy) in patients with metastatic colon cancer refractory to oxaliplatin containing chemotherapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Dose limiting toxicity, safety
Key secondary outcomes
Response rate, overall survival, progression free survival, disease control rate
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 150mg/m2(day1)
Capecitabine Xmg/m2, p.o.(day2-8)
to be repeated every 2 weeks for four course
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. histologically proven colon or rectum cancer
2. Patients with tumor resistant to oxaliplatin after one or more courses of oxaliplatin treatment
3. Written informed consent
4. Age: 20-75 yo
5. Performance status: 0-2 (ECOG criteria)
6. A predicted life expectancy of at least 3 months.
7. With prior chemotherapy completed before more than 14 days
8. with sufficient bone marrow, renal or hepatic function
WBC: 3,000 /mm3 <= and =< 12,000/mm3
Neutrocyte: 1,500/mm3=<
Platelet: 100,000/mm3 =<
Hemoglobin: 8.0 g/dl =<
Total bilirubin: 1.5 >=
GOT, GPT: 100 >
Creatinine: 1.2mg/dl =>
Creatinine clearance : 60 <=
9. Ability of oral intake
Key exclusion criteria
1) with treatments including CPT-11
2) with active double cancers
3) Any other serious illness or medical condition(s) including ileus, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, etc.
4) Infectious disease
5) Diarrhea (watery stools)
6) with obstruction or disorder on digestive tract due to peritoneal metastasis
7) with ascites and/or pleural fluid
8) History of serious drug hypersensitivity
9) Undergoing anti-fungal treatment with fluorocytosine, or atazanavir sulfate.
10) Found to have fresh gastrointestinal bleeding that requires repeated transfusion.
11) With liver cirrhosis or jaundice.
12) patients undergoing treatment with a psychotropic agent or who have a mental disorder that seems to require treatment.
13) having heart disease, such as ischemic heart disease or an arrhythmia, which require treatment.
14) With diabetes that is difficult to control.
15) With central nervous system metastasis
16) Patients with UGT1A1 genotype *6/*6, *28/*28 and *6/*28
17) women pregnant, breast-feeding, or who wish pregnancy
18) Any other patient whom the physician in charge of the study judges to be unsuitable
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naotoshi Sugimoto |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Medical Oncology
Zip code
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naotoshi Sugimoto |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Medical Oncology
Zip code
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL
Homepage URL
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
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 | 02 | Month | 12 | 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
Completed
Date of protocol fixation
| 2010 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | 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
| 2010 | Year | 02 | Month | 12 | Day |
Last modified on
| 2017 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003851
