Squamous cell carcinoma of the head and neck
Conditions
Interventions
According to the dose-escalation scheme, docetaxel is administered intravenously at a dose of 50, 60, or 70 mg/m2 on day 1
70mg/m2 of cisplatin infusion on day 1
continuous 750 mg/m2/d of 5-fluorouracil infusion on days 1 through 5.
Sponsors
Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, University of Yamanashi
Department of Otolaryngology, Keiyukai Sapporo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed head and neck squamous cell carcinoma. 2) Stage III or IV disease. 3) Measurable disease according to RECIST criteria. 4) ECOG Performance Status 0 to 1. 5) No prior treatment for head and neck cancer. 6) No prior chemotherapy for any malignant disease. 7) Oral intake is possible. 8) Life expectancy >= 3 months. 9) The patient's laboratory data 14 days before starting chemotherapy is as follows: Hemoglobin >= 9.0 g/dl, WBC >= 4000 /mm3, WBC <= 12000 /mm3, Neutrophil >= 2000 /mm3, Platelets >= 100000 /mm3, T-Bil <= 1.5 mg/dl, GOT <= 2.5 times upper limit of normal (ULN), GPT <= 2.5 times upper limit of normal (ULN), Ccr >= 60 ml/min/body, and SpO2 (Room air) >= 95%. 10) The patient who have given written informed consent to participant in this study.
Exclusion criteria
Exclusion criteria: 1) Active multiple cancers. (only as for the phase I period) 2) Active infection disease with fever. 3) Serious complications (such as, heart failure, pulmonary fibrosis, interstitial pneumonia, and hemorrhagic tendency). 4) Metastasis to brain. 5) Pleural effusion or ascites requiring continuous drainage. 6) Pericardial effusion requiring treatment. 7) Edema grade 2 or more. 8) Previous history of severe drug hypersensitivity. 9) The patient who is pregnant, lactating, and potentially pregnant or hopes to become pregnant. 10) Long-term use of steroids. 11) The patient who has been judged to be ineligible for participating in this study by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the DLT, MTD, and RD in phase I setting. The objective response rate at the RD in phase II setting. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients who received a second round of TPF chemotherapy on schedule and the proportion of patients completed two cycles of TPF chemotherapy in phase I setting. The overall survival, the progression-free survival, and the adverse events in phase II setting. | — |
Countries
Japan
Contacts
Public ContactAkihito Watanabe
Keiyukai Sapporo Hospital Department of Otolaryngology
Outcome results
None listed