Phase II study of biweekly cetuximab and irinotecan as third-line therapy in patients with pre-treated KRAS exon2 wild-type metastatic colorectal cancer

Phase II study of biweekly cetuximab and irinotecan as third-line therapy in patients with pre-treated KRAS exon2 wild-type metastatic colorectal cancer - Phase II study of biweekly cetuximab and irinotecan as third-line therapy in patients with pre-treated KRAS exon2 wild-type metastatic colorectal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019893

Enrollment

Registered

2015-11-24

Start date

2011-10-24

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

Metastatic colorectal cancer

Interventions

Cetuximab 500 mg/M2/2week Irinotecan 150 mg/M2/2week

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Written IC. Pathologically diagnosed colorectal adenocarcinoma. Unresectable colorectal cancer. No KRAS mutation (codon 12 or codon13). Age over 20 years old and under 75 years. ECOG PS0-2. Target lesion(RECIST 1.0). Previously treated within 2 regimens and Wihtout cetuximab. at least 2 week rest. 2 months or longer expected survival. Adequate organ function.

Exclusion criteria

Exclusion criteria: Receive blood infusion, G-CSF within 7days before primary registration. UGT1A1*28 homo, *6 homo,*28*6 Severe heart disease. Severe liver disease. Severe lung disease. Active gastrointestinal bleeding. Severe mental disease. Severe diabetes. Ileus. Active infectious disease. Other active cancer. Cerebral metastasis. Icterus . Severe diarrhea. Severe allergic reaction for drugs (irinotecan anti-EGFR antibody). Massive ascites, plerural effusion. Under treatment with atazanavir. Past history of treatment with EGFR antibody. Alcoholic or drug Intoxication. Hbs antibody positive. HCV antibody positive. HIV antibody positive. A pregnant woman, a woman in breast-feeding, a man who expects his baby. An inappropriate case judged by docter in charge.

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression free survival Overall survival Pharmacokinetic parameter Safety profile	—

Countries

Japan

Contacts

Public ContactEiji Shinozaki

The Cancer Institute Hospital, Japanese Foundation for Cancer Research Department of Gastroenterology

eiji.shinozaki@jfcr.or.jp03-3520-0111

Outcome results

None listed

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