Phase II Trial of Chemotherapy with Docetaxel plus Cisplatin for Patients with Recurrent or Metastatic Non-squamous Cell Carcinoma of Head and Neck

Phase II Trial of Chemotherapy with Docetaxel plus Cisplatin for Patients with Recurrent or Metastatic Non-squamous Cell Carcinoma of Head and Neck - HN non-SCC_P2_DC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008333

Enrollment

Registered

2012-09-01

Start date

2012-09-01

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

Patients with recurrent or metastatic non-squamous cell carcinoma of head and neck

Interventions

Docetaxel 75 mg/m2 + Cisplatin 75 mg/m2 q3weeks 6 cycles

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathologically proven head and neck non squamous cell carcinoma (HN-nonSCC) 2) Unresectable recurrent or metastatic disease 3) Prior chemotherapies defined as the follows a) NOT include platinums, or previous platinums completed at 24 weeks from progression b) NOT include taxanes 4) Progressive disease defined as one of the following occurring within 6 months of study entry a) At least a 20% increase in radiologically or clinically measurable disease b) Appearance of new lesions c) Deterioration in clinical status 5) One or more measurable lesions 6) Aged 20 years or older 7) ECOG perfomance status 0-1 8) Adequate bone marrow, hepatic, renal and cardiopulmonary function 9) Life expectancy of at least 12 weeks 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Interval of at least 4 weeks from last surgery or radiotherapy, or interval of at least 2 weeks from last chemotherapy 2) Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage 3) Active infection 4) Active concomitant malignancy 5) Symptomatic CNS metastases 6) Patients with uncontrollable complications 7) Pregnant, breast-feeding, or unwilling to use adequate contraception 8) HBsAg-positive 9) Other conditions inadequate for this research

Design outcomes

Primary

Measure	Time frame
Objective response rate	—

Secondary

Measure	Time frame
Disease control rate, Overall survival, Progression free survival, Adverse events	—

Countries

Japan

Contacts

Public ContactYoshinori Imamura

Kobe University Hospital and Graduate School of Medicine Medical Oncology / Hematology, Department of Medicine

yimamura@med.kobe-u.ac.jp078-382-5820

Outcome results

None listed

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