UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of a combination of capecitabine plus CPT-11 (CC therapy) in patients with metastatic colon cancer refractory to oxaliplatin containing chemotherapy
Title of the study (Brief 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
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	Naotoshi Sugimoto
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Medical Oncology
Address	1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL
Email

Public contact
Name of contact person	Naotoshi Sugimoto
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Medical Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 01 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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