Phase II Trial of Chemotherapy with Docetaxel plus Cisplatin for Patients with Recurrent or Metastatic Non-squamous Cell Carcinoma of Head and Neck
- Conditions
- Patients with recurrent or metastatic non-squamous cell carcinoma of head and neck
- Registration Number
- JPRN-UMIN000008333
- Lead Sponsor
- Medical Oncology / Hematology, Department of Medicine Kobe University Hospital and Graduate School of Medicine
- Brief Summary
DC regimen demonstrated promising efficacy in patients with R/M HN non-SCC. - ORR 45.5%, DCR 95.5% - mPFS 6.7 months, mOS 20.1 months No treatment-related deaths were observed. - FN 39% Prophylactic antibiotics seems to be effective. - 57 vs 11% (post-hoc analysis)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 23
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate
- Secondary Outcome Measures
Name Time Method Disease control rate, Overall survival, Progression free survival, Adverse events