Cetuximab in combination with S-1 in Treating Patients With Metastatic or Unresectable Head and Neck Cancer

Cetuximab in combination with S-1 in Treating Patients With Metastatic or Unresectable Head and Neck Cancer - C-mab+S-1 in Treating Patients With Metastatic or Unresectable Head and Neck Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010310

Enrollment

Registered

2013-04-01

Start date

2013-04-01

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

Head and Neck cancer

Interventions

Cetuximab:400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY. Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations. S-1:A fixed dose of 80,100 or 120 mg/pa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirmed carcinoma of the head and neck 2)20 Years and older 3)written informed consent 4)ECOG performance status (PS) 0-2 5)Absolute neutrophil count >= 1,500/mm3 6)Platelet count >= 100,000/mm3 7)Hemoglobin >=9.0 g/dL (without transfusions) 8)Bilirubin <=1.5 times upper limit of normal(ULM) 9)AST and ALT <= 5 times upper limit of normal (ULN) 10)Creatinine normal OR creatinine clearance >=50 mL/min

Exclusion criteria

Exclusion criteria: 1)Known hypersensitivity to S-1, fluorouracil, cisplatin, cetuximab or to any of the excipients of these drugs 2)Being treated with other pyrimidine fluoride antineoplastic agents, flucytosine or therapeutic anticoagulation (prophylactic use of warfarin 1 mg per day is allowed) 3)Known Human Immunodeficiency Virus (HIV) infection, active or chronic carrier of hepatitis B virus (HBV) (HBV antigen positive or HBV deoxyribonucleic acid (DNA) positive) or hepatitis C virus (HCV) (HCV antibody positive) 4)Current severe infection, or suspicious of severe infection 5)Significant comorbid disease such as paresis of intestine and ileus. 6)Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest CT 7)Uncontrolled diabetes mellitus 8)Severe heart disease or liver disease 9)Pregnant women are excluded from this study because cetuximab has the potential for teratogenic or abortifacient effects. Women of child-bearing potential and men are also exluded. 10)Inappropriate patients for this study judged by the attending physician

Design outcomes

Primary

Measure	Time frame
the objective response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST)	—

Secondary

Measure	Time frame
Overall Survival Progression-Free Survival Safety Patients' Quality of life	—

Countries

Japan

Contacts

Public ContactJunkichi Yokoyama

Juntendo university faculty of medicine Department of Otorhinolaryngology, head and neck surgery

Outcome results

None listed

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