PhaseII study of Combination FOLFIRI with Cetuximab in patients with advanced/metastatic colorectal cancer previously received oxaliplatin-based chemoterapy.

PhaseII study of Combination FOLFIRI with Cetuximab in patients with advanced/metastatic colorectal cancer previously received oxaliplatin-based chemoterapy. - PhaseII study of Combination FOLFIRI with Cetuximab in patients with advanced/metastatic colorectal cancer previously received oxaliplatin-based chemoterapy.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007372

Enrollment

Registered

2012-02-24

Start date

2011-09-01

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

Colorectal Cancer

Interventions

FOLFIRI (CPT-11, 5-FU bolus, 5-FU infusional, l-LV)+ Cetuximab 1) Cetuximab : 500 mg/m2/bi-week 2) CPT-11 : 100 or 150 mg/m2/bi-week 3) l-LV : 200 mg/m2/bi-week 4) 5-FU/bolus : 400 mg/m2/bi-week

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients with histologically proven colorectal cancer (2)EGFR expression in the primary or metastatic tumor tissue is confirmed by immunohistochemical evaluation regardless of intensity (3)KRAS wild type in codon 12 and 13 in the primary or metastatic tumor tissue is confirmed (4)Curatively unresectable mCRC patients who had received and failed at least one regimen of oxaliplatin-contained chemotherapy (5)Age 20 years<= (6)ECOG performance status 0-1 (7)Presence of at least one measurable lesion (according to the RECIST) (8)Prior chemotherapy was done in the first study treatment before at least 28days (9)Patiens have enough organ function for study treatment 1. WBC>=3,000/mm3 , Neurtophils>=1,500/mm3 2. Platelets>=100,000/mm3 3. Hemoglobin>=9.0g/dl 4. Total bilirubin<=upper limit of normal (ULN)*3 5. AST and ALT<=upper limit of normal (ULN)*3 (<=ULN*5 in case of liver metastasis) 6. Creatinine<=upper limit of normal (ULN)*2 (10)Life expectancy of 3 months (11)Written informed consent

Exclusion criteria

Exclusion criteria: (1)Severe bone marrow suppression (2)Wattery diarrhea (3)Severe infectious disease (4)Massive pleural effusion or ascites (5)Comorbidity or history of heart failure (6)Comorbidity or history of interstitial lung disease or pulmonary fibrosis (7)Paralytic or mechanical bowel obstruction (8)Jaundice (9)Patients who is receiving Atazanavir Sulfate (10)History of severe allergy (11)Pregnant or lactating women or women of childbearing potential (12)Severe comorbidity (uncontrolable diabetes, hypertension, hypercarcemia etc) (13)Symptomatic brain metastasis (14)Simultaneous or metachronous double cancers (15)Any other cases who are regarded as inadequate for study enrollment by the investigator

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression free survival response rate according to internal organs Disease control rate(CR+PR+SD) Dose Intensity Safety	—

Countries

Japan

Contacts

Public ContactYoshito Akagi

Kurume University Department of Surgery

yoshisg@med.kurume-u.ac.jp0942-35-3311

Outcome results

None listed

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