Capecitabine in combination with chemotherapy in patients with advanced and/or metastatic gastric cancer suitable to be treated with a fluoropirimidine based regimen to assess the safety profile specifically the incidence of Hand –Foot Syndrom. MedDRA version: 8.1 Level: LLT Classification code 10017758 Term: Gastric cancer
Conditions
Interventions
Trade Name: Xeloda
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Capecitabina
CAS Number: 154361-50-9
Current Sponsor code: RO09-1978
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Roche Farma, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed inform consent prior to any study specific procedure. 2. Advanced or metastatic gastric Adenocarcinoma histológically confirmed. 3. Age> 18. 4. Creatinina clearance > 60 mi/min, measured at baseline based on Cockroff – Gault formula (In case that the creatinitn clearance calculated by the formula is 60 ml/min, the patient is elegible). 5. ECOG =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactatig woman. Woman with reproductive potential unless using an effective method of contraception (Postmenopausic woman must have been amenorreic during at least 12 months). 2. Previous chemotherapy (except if administered as adjuvant or neoadyuvant treatment and was finalized at least 6 months prior recruitment) 3. Organ transplant (liver and kidney) 4. Cardiac disease clinically significant (for example, congestive heart failure, clinically significant valvular heart disease, high risk uncontrollable arrithmias) or myocardial infarction during the last 12 months. 5. Evidence of metastasis in the central nervous system (CNS). 6. History of any other neoplasia during the last 5 years at exception of cellular basal carcinoma of skin already cured and in-situ carcinoma of the cérvix uterus already cured. 7. Laboratory values:: • neutrófils 1.5 x upper normal limit. • ALT, AST > 2.5 x upper normal limit o > 5 x upper normal limit in case of hepatic metastasis. • Alkaline Phosphatase > 2.5 upper normal limit o 5 x upper normal limit in case of hepatic metastasis o > 10 x upper normal limit in case of bone disease) 8. Major surgery within 4 weeks of start of study treatment, without complete recovery. 9. Receive any investigational drug treatment within 4 weeks of start of study treatment. 10. Intercurrent infections uncontrolled. 11. Patients with serious malabsortion syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): To assess the incidence of Hand Foot Syndrom of capecitabine when combined with chemotherapy as first-line treatment of advanced and/or metastatic gastric cancer;Main Objective: To assess the safety profile of capecitabine when combined with chemotherapy as first-line treatment of advanced and/or metastatic gastric cancer, specifically the incidence of Hand –Foot Syndrom.;Secondary Objective: To assess the efficacy profile (overall response rate, survival time, duration of response, time to response). | — |
Countries
Spain
Outcome results
None listed