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) studied | Unresectable advaned or recurrent colorectal cancer |
| Date of first enrollment | 2008/10/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | cetuximab plus irinotecan |
Outcome(s)
| Primary Outcome | Response rate |
|---|---|
| Secondary Outcome | disease control rate, duration of response, 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 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
| Primary Sponsor | Aichi Cancer Center Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Aichi Cancer Center Hospital |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kohei Shitara |
| Address | , 1-1 Kanokoden, Chikusa-ku, Nagoya 464-0011, Aichi, Japan. Japan |
| Telephone | 052-762-6111 |
| 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 |
| Affiliation | Aichi Cancer Center Hospital Department of Clinical Oncology |