Paclitaxel with biweekly cetuximab for platinum- and immune checkpoint inhibitor-refractory head and neck cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051200040

Enrollment

Registered

2020-07-30

Start date

2020-08-17

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 squamous cell carcinoma Head and neck cancer, squamous cell carcinoma

Interventions

Paclitaxel + cetuximab combination therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically proven squamous cell carcinoma of head and neck Recurrent or metastatic or unresectable head and neck cancer patient with refractory of platinum and anti PD-1/PD-L1 treatment. - Definition of refractory of platinum: Progression in six months after last platinum contained chemotherapy or chemoradiotherapy. - Definition of refractory of anti PD-1/PD-L1: Progression during treatment with anti PD-1//PD-L1 treatment. Age 20 years or older, signed informed consent obtained before any study specific procedures. No previous taxane chemotherapy as prior systemic palliative chemotherapy. ECOG-PS of 0 to 2. Life expectancy of 12 weeks or longer. Adequate bone marrow, liver function assessed within 14 days before starting study treatment. - Neutrophils counts >= 1000/mm3 - Hb >= 8.0 g/dl - Platelet counts>= 75000/mm3 - Total bilirubin: =< 1.5 mg/dl (In case of patient with constitutional jaundice, total bilirubin is allowed =< 3.0 mg/dl) - AST/ALT =< 100/100 IU/l (If patient has liver metastasis, AST/ALT is allowed =< 200 IU/l)

Exclusion criteria

Exclusion criteria: Primary sites are thyroid, salivary gland, skin, or eye. Active concomitant malignancy except carcinoma in situ or intramucosal tumor within 5 years before study entry. Residual peripheral neuropathy CTCAE Grade 2. Severe allergy/infusion reaction (Grade 3/4) or side effect for paclitaxel or cetuximab. HIV infected patient. Surgery or radiotherapy within 4 weeks before study entry. Pleural effusion, ascites and/or pericardial effusion requiring drainage frequency within two weeks. Symptomatic central nervous system metastases. Lung fibrosis, acute lung damage or intestinal lung disease. Hemodialysis or peritoneal dialysis patients. Active uncontrolled infection disease needed treatment. Active disseminated intravascular coagulation.

Design outcomes

Primary

Measure	Time frame
Objective Response;OR	—

Secondary

Measure	Time frame
Progression Free Survival ( PFS ) Overall Survival ( OS ) Disease control rate ( CR or PR or SD ) Adverse effect on CTCAE v5.0	—

Contacts

Public ContactTaiji Koyama

Kobe university hospital

hameyama@med.kobe-u.ac.jp+81-78-382-5111

Outcome results

None listed

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