A phase II study of Capecitabine in combination with Cisplatin in advanced head and neck Cancer - ND

Conditions: Advanced or metastatic head and neck cancer
Level: HLTClassification code 10024530

Registration Number: EUCTR2006-003775-13-IT

Lead Sponsor: OSPEDALE ONCOLOGICO DI BARI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 43

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures