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

Phase 2

Recruiting

• Conditions: Head and neck squamous cell carcinoma; Head and neck cancer, squamous cell carcinoma; D000077195

• Registration Number: JPRN-jRCTs051200040
• Lead Sponsor: Kiyota Naomi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified