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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003176
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003851

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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