Unique ID issued by UMIN | UMIN000020357 |
---|---|
Receipt number | R000023496 |
Scientific Title | Phase I study to optimize the safe starting dose of weekly paclitaxel |
Date of disclosure of the study information | 2016/01/04 |
Last modified on | 2015/12/25 23:00:57 |
Phase I study to optimize the safe starting dose of weekly paclitaxel
Optimizing the starting dose of paclitaxel
Phase I study to optimize the safe starting dose of weekly paclitaxel
Optimizing the starting dose of paclitaxel
Japan |
head and neck cancer
Oto-rhino-laryngology |
Malignancy
NO
Optimizing the starting dose of weekly paclitaxell
Safety
Starting dose to determine the individualized maximum repeatable dose
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Administration of Paclitaxel
20 | years-old | <= |
75 | years-old | >= |
Male and Female
Eligibility criteria included histologically or cytologically proven head and neck carcinoma with recurrent or metastatic disease; age 20 years or older but less than 75; measurable lesions; Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2; adequate organ function, as defined by an absolute neutrophil count (ANC) >2,000, white blood cell count 4,000, platelet count >100,000, hemoglobin >9.0 g/dL, transaminase levels less than 2.5 times the upper limits of normal, ALP, total bilirubin, and serum creatinine less than 1.5 times the upper limits of normal; and life expectancy >3 months from the beginning of treatment. Patients were excluded if they had received three or more prior regimens of chemotherapy for recurrent or metastatic head and neck cancers.
Patients with severe co-morbidity are excluded
24
1st name | |
Middle name | |
Last name | Naohiro Wakisaka |
Kanazawa University
Otolaryngology, and Head & Neck Surgery
13-1 Takara-machi, Kanazawa
076-265-2413
jibiinfo@med.kanazawa-u.ac.jp
1st name | |
Middle name | |
Last name | Naohiro Wakisaka |
Kanazawa University
Hospital
13-1 Takara-machi, Kanazawa
076-265-2413
jibiinfo@med.kanazawa-u.ac.jp
Kanazawa University
Not applicable
Other
NO
2016 | Year | 01 | Month | 04 | Day |
Unpublished
Completed
2012 | Year | 07 | Month | 31 | Day |
2012 | Year | 12 | Month | 01 | Day |
2015 | Year | 12 | Month | 25 | Day |
2015 | Year | 12 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023496
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |