UMIN ID: UMIN000001951
Registered date:11/05/2009
Phase II study of biweekly cetuximab plus irinotecan for unresectable colorectal cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Unresectable colorectal cancer |
| Date of first enrollment | 2009/04/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Biweekly cetuximab plus irinotecan |
Outcome(s)
| Primary Outcome | response rate |
|---|---|
| Secondary Outcome | disease control rate, duration of progression free survival, overall survival, toxicity, biomarker analysis |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Symptomatic brain metastasis Wattery 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
| Primary Sponsor | Aichi Cancer Center Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Aichi Cancer Center Hospital |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| kshitara@aichi-cc.jp | |
| Affiliation | Aichi Cancer Center Hospital Department of Clinical Oncology |
| scientific contact | |
| Name | Kohei Shitara |
| Address | 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan. Japan |
| Telephone | |
| Affiliation | Aichi Cancer Center Hospital Department of Clinical Oncology |