Phase II study of cetuximab plus irinotecan for unresectable colorectal cancer

Phase II study of cetuximab plus irinotecan for unresectable colorectal cancer - Phase II study of cetuximab plus irinotecan for colorectal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001838

Enrollment

Registered

2009-04-01

Start date

2008-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable advaned or recurrent colorectal cancer

Interventions

cetuximab plus irinotecan

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histological proven colorectal cancer No KRAS mutation Measurable lesions according to RECIST Following previous treatment refractory to irinotecan refractory or failure to 5FU and oxaliplatin Age 20 or older Written informed consent from patient

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
disease control rate, duration of response, progression free survival, overall survival, toxicity, biomarker analysis	—

Countries

Japan

Contacts

Public ContactKohei Shitara

Aichi Cancer Center Hospital Department of Clinical Oncology

kshitara@aichi-cc.jp052-762-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026