NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001365

Registered date:10/09/2008

Phase I/II study of triweekly administration regimen of irinotecan and TS-1 in patients with advanced colorectal cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedadvanced colorectal cancer
Date of first enrollment2004/12/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Treatment : TS-1+CPT-11

Outcome(s)

Primary Outcome1) Phase I To determine the recommended dose 2) Phase II Response Rate
Secondary OutcomeSafety, Overall survival, Progression free survival

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria(1) Histological confirmation of colorectal cancer (2) Advanced colorectal cancer (3) Measurable disease (4) No prior chemotherapy/radiotherapy (5) ECOG-PS:0-2 (6) Adequate major organ function (7) All patients provided written informed consent
Exclude criteria(1) Massive pleural effusion or massive ascites (2) Symptomatic brain metastases (3) Active diarrhea

Related Information

Contact

public contact
Name Hitoshi Kusaba
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka812-8582, Japan Japan
Telephone 092-642-5232
E-mail
Affiliation Kyushu University Hospital Division of Hematology and Oncology
scientific contact
Name Eishi Baba
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka812-8582, Japan Japan
Telephone 092-642-5232
E-mail
Affiliation Kyushu University Hospital Division of Hematology and Oncology