Advanced or metastatic head and neck cancer Level: HLT Classification code 10024530
Conditions
Interventions
Trade Name: XELODA*120CPR RIV 500MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Capecitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Trade Name:
Sponsors
OSPEDALE ONCOLOGICO DI BARI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Advanced loco-regional and/or metastatic recurrence of head and neck squamous cell carcinoma histologically or cytologically proven 2. No previous treatment with chemotherapy 3. Age 18 and 75 years 4. Life expectancy 3 months 5. Normal cardiac function 6. No gastrointestinal disorders that might affect the gastrointestinal absorption of Capecitabine Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of prior malignancy in the last 10 years 2. Concurrent treatment with other experimental drugs or participation in another clinical trial with ant investigational drug within 30 days prior to study screening 3. ASAT SGOT and/or ALAT SGPT 1.5 x UNL associated with alkaline phosphatase 2.5 x UNL 4. Other serious illness or medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the Response Rate RR of the combination of capecitabine with cisplatin in the treatment of patients with advanced or recurrent head and neck cancer;Secondary Objective: 1. To assess the safety of this combination 2. To assess the Time to Progression TTP 3. To assess the Overall Survival OS ;Primary end point(s): To assess the safety of the combination Capecitabine with Cisplatin in advanced head and neck cancer | — |
Countries
Italy
Outcome results
None listed