Phase II clinical trial of Cetuximab with Fluorouracil therapy for patients refractory or intolerable to Oxaliplatin and Irinotecan with KRAS wild-type unresectable/recurrent colorectal cancer

Phase II clinical trial of Cetuximab with Fluorouracil therapy for patients refractory or intolerable to Oxaliplatin and Irinotecan with KRAS wild-type unresectable/recurrent colorectal cancer - Phase II clinical trial of Cetuximab with Fluorouracil therapy for patients with KRAS wild-type unresectable/recurrent colorectal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008377

Enrollment

Registered

2012-07-08

Start date

2012-07-08

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

colorectal cancer

Interventions

(Cetuximab with Fluorouracil therapy) Cetuximab=400mg/m2 (day1)Cetuximab=250mg/m2/weekly(day 8-) with 1) l-LV=200mg/m2/bi-week 5-FU/bolus=400mg/m2/bi-week 5-FU/infusional=2,400mg/m2/bi-wee

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histopathological confirmation of Adenocarcinoma 2) EGFR expression confirmed by immunohistochemistry either in the primary tumor or in metastatic tumor lesion 3) KRAS wild type (in codon 12, 13) confirmed, either in the primary tumor or in metastatic tumor lesion 4) Patients refractory or intolerable to Oxaliplatin and Irinotecan 5) Age of 20 or more years old 6) ECOG performance status of 0 to 2 7) Presence of at least one measurable lesion according to RECIST 8) Sufficient oral intake 9) Sufficient function of important organs 1. WBC:>= 2,000 /mm3 2. Neu: >= 1,500 /mm3 3. Platelet: >= 75,000 /mm3 4. Hemoglobin: >= 8.0 g/dL 5. Sr.bil : <= 2.0 mg/dL 6. AST, ALT: <= upper limits of normal (ULN)x2.5 (patients with liver metastasis; AST, ALT : <= ULNx5.0) 7. Serum creatinine: <= ULNx1.5 10) Expected more than 3 months survival 11) With written informed consent

Exclusion criteria

Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 2) Patients with brain metastasis which have symptoms or patients with history of brain metastasis 3) Severe wattery diarrhea 4) Severe infectious disease 5) Severe complications (interstitial lung disease or pulmonary fibrosis, kidney failure, hepatic failure, uncontrolable diabetes, uncontrolable hypertension) 5) History of interstitial lung disease or pulmonary fibrosis 6) Severe carcinomatous ascites, pleural effusion or pericardial cavity effusion 7) Pregnant or lactating women or women of childbearing potential, and no birth-control 8) Patients with history of serious hypersensitivity 9) Patients who received the anti-EGFR antibodies within 3 months 10) Any other cases who are regarded as inadequate for study enrollment by the investigator

Design outcomes

Primary

Measure	Time frame
Progression-free survival; PFS	—

Secondary

Measure	Time frame
Response Rate; RR, Overall survival; OS, Safety	—

Countries

Japan

Contacts

Public ContactTakeshi Nagasaka

Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Department of Gastroenterological Surgery

takeshin@cc.okayama-u.ac.jp086-235-7257

Outcome results

None listed

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