Head and Neck Cancer
Conditions
Brief summary
The purpose of this clinical research study is to learn if a paclitaxel-cisplatin combination regimen given in the neoadjuvant setting is active in locally advanced head and neck cancer. the safety of this treatment will also be studied.
Interventions
DRUGPaclitaxel
Sterile solution mixed with 0.9% saline or 5% glucose solution 500mL, 3-hour Continuous infusion, Level 0: 175 mg/m2, Level 1: 140 mg/m2, Level 2: 105 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days.
DRUGcisplatin
solution mixed with 0.9% saline 500mL, 30 to 90 min intravenous infusion, Level 0: 75 mg/m2, Level 1: 60 mg/m2, Level 2: 45 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Inclusion criteria
* Locally advanced, Stage II-IV (except M1), hand and neck cancer * \> = 1 measurable lesion * not been previously treated for head and neck cancer
Exclusion criteria
* history of another malignancy * organ allografts * pre-exiting neuropathy \> = CTC grade 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response rate of locally advanced head and neck cancer to a paclitaxel-cisplatin combination regimen in a neoadjuvant setting and administered during maximum 3 cycles. | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity for maximum 3 cycles | — |
Countries
South Korea
Outcome results
None listed