NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001838

Registered date:01/04/2009

Phase II study of cetuximab plus irinotecan for unresectable colorectal cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedUnresectable advaned or recurrent colorectal cancer
Date of first enrollment2008/10/01
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)cetuximab plus irinotecan

Outcome(s)

Primary OutcomeResponse rate
Secondary Outcomedisease control rate, duration of response, progression free survival, overall survival, toxicity, biomarker analysis

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaSymptomatic brain metastasis Wartery diarrhea Paralytic or mechanical bowel obstruction confirmed or suspected infection Severe pulmonary disease (interstitial pneumonia, pulmonary fobrosis, severe emphysematous) Severe comorbidity (uncontrolable diabetes, heart failure with NYHA 3 or 4, renal failure, liver failure) Sever neurologic disease history of irinotecan allergy past history of treatment with EGFR antibody

Related Information

Contact

public contact
Name Kohei Shitara
Address , 1-1 Kanokoden, Chikusa-ku, Nagoya 464-0011, Aichi, Japan. Japan
Telephone 052-762-6111
E-mail kshitara@aichi-cc.jp
Affiliation Aichi Cancer Center Hospital Department of Clinical Oncology
scientific contact
Name Kei Muro
Address , 1-1 Kanokoden, Chikusa-ku, Nagoya 464-0011, Aichi, Japan. Japan
Telephone 052-762-6111
E-mail
Affiliation Aichi Cancer Center Hospital Department of Clinical Oncology