Combination chemotherapy with docetaxel, cisplatine, and 5-fluorouracil for patients with advanced head and neck cancer: a phase I/II trial
Phase 1
- Conditions
- Squamous cell carcinoma of the head and neck
- Registration Number
- JPRN-UMIN000000744
- Lead Sponsor
- Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, University of Yamanashi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 53
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determine the DLT, MTD, and RD in phase I setting. The objective response rate at the RD in phase II setting.
- Secondary Outcome Measures
Name Time Method 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.